Device manufacturer, as written on reports

Allergan: medical device reports filed with FDA

9,443 reports name it as the manufacturer of the device involved, 1996–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

9,443
reports naming it as manufacturer: 0% of all MAUDE reports; 50
reports, 12 months to August 2026: 81 in the 12 months before; 34.9%
classified as malfunction: 62.3% across all reports; 1%
classified as death, as reported: 0.9% across all reports

9,443 medical device reports received by FDA give Allergan as the manufacturer of the device involved, 0% of the MAUDE database, from August 1996 to June 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

50 reports arrived in the 12 months to August 2026, down 38% from 81 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (63.4%), malfunction (34.9%) and death (1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Lap-Band Adjustable Gastric Banding System Unk Size	Implant, intragastric for morbid obesity	1,771	0	2%
Lap-Band Ap Adjustable Gastric Banding System Standard	Implant, intragastric for morbid obesity	781	0	0.4%
Lap-Band Adjustable Gastric Banding System 10 0cm	Implant, intragastric for morbid obesity	416	0	0.4%
Lap-Band Ap Adjustable Gastric Banding System Small	Implant, intragastric for morbid obesity	412	0	1.1%
Lap-Band Ap Adjustable Gastric Banding System Large	Implant, intragastric for morbid obesity	409	0	1.1%
Lap-Band Adjustable Gastric Banding System Vg	Implant, intragastric for morbid obesity	210	0	0.8%
Lap-Band Adjustable Gastric Banding System 9 75cm	Implant, intragastric for morbid obesity	201	0	0.1%
Juvederm Ultra Plus Xc Tsk Us	Implant, dermal, for aesthetic use	140	5	0%
Juvederm Ultra Xc Tsk Us	Implant, dermal, for aesthetic use	103	1	0%
Juvederm Voluma XC 27G 2 x 1mL	Implant, dermal, for aesthetic use	91	78	0%
Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	76	97	1.3%
Breast Implants	Prosthesis, breast, noninflatable, internal, silicone gel-filled	71	20	1.1%
Juvederm VOLUMA WITH LIDOCAINE 1mL	Implant, dermal, for aesthetic use	69	23	0%
Juvederm Voluma With Lidocaine 1ml Sku1	Implant, dermal, for aesthetic use	63	0	0%
UNK Mammary Implant	Prosthesis, breast, inflatable, internal, saline	44	1,887	0.2%
Style 410 Cohesive Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	43	1,841	0.1%
Juvederm Voluma Xc/Lido Volume Unknown	Implant, dermal, for aesthetic use	37	194	0.1%
Style 20 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	28	981	0.1%
Silicone Breast Implants	Prosthesis, breast, noninflatable, internal, silicone gel-filled	24	2	0%
Style 15 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	24	1,529	0.1%
Style 68 Saline Filled Breast Implant	Prosthesis, breast, inflatable, internal, saline	17	3,064	0%
UNK Gel Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	17	782	0.4%
Allergan Cup	Accessories, solution, ultrasonic cleaners for lenses	14	0	0%
Mcghan	Prosthesis, breast, inflatable, internal, saline	12	0	0%
Saline Breast Implants	Prosthesis, breast, inflatable, internal, saline	11	2	0%
Silicone Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	11	5	0.4%
Style 168 Saline Filled Breast Implant	Prosthesis, breast, inflatable, internal, saline	10	318	0.1%
Juvederm Ultra Xc 1 Ml Coc	Implant, dermal, for aesthetic use	8	0	0%
Juvederm Ultra/24hv Volume Unknown	Implant, dermal, for aesthetic use	8	9	0%
Style 120 Silicone Gel Filled Breast Implant	Prosthesis, breast, noninflatable, internal, silicone gel-filled	6	212	0.1%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
LTI	Implant, intragastric for morbid obesity	5,136	54.4%
FTR	Prosthesis, breast, noninflatable, internal, silicone gel-filled	2,486	26.3%
LMH	Implant, dermal, for aesthetic use	1,540	16.3%
FWM	Prosthesis, breast, inflatable, internal, saline	767	8.1%
OXF	Mesh, surgical, absorbable, plastic and reconstructive surgery	200	2.1%
HQC	Unit, phacofragmentation	121	1.3%
LCJ	Tissue expander and accessories	113	1.2%
HQL	Intraocular lens	92	1%
LPN	Accessories, soft lens products	74	0.8%
MFK	Lens, multifocal intraocular	42	0.4%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death1%92

Injury63.4%5,988

Malfunction34.9%3,299

Other0.3%25

Not given0.4%39

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Allergan reports

How many FDA device reports name Allergan as manufacturer?

9,443 reports through August 2026, 50 of them in the latest 12 months.

Which of its brands appear most often?

Lap-Band Adjustable Gastric Banding System Unk Size (1,771), Lap-Band Ap Adjustable Gastric Banding System Standard (781), Lap-Band Adjustable Gastric Banding System 10 0cm (416), Lap-Band Ap Adjustable Gastric Banding System Small (412) and Lap-Band Ap Adjustable Gastric Banding System Large (409).

Which device types does it report on?

implant, intragastric for morbid obesity (54.4%), prosthesis, breast, noninflatable, internal, silicone gel-filled (26.3%), implant, dermal, for aesthetic use (16.3%) and prosthesis, breast, inflatable, internal, saline (8.1%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.