Device manufacturer, as written on reports

Caldera Medical: medical device reports filed with FDA

1,077 reports name it as the manufacturer of the device involved, 2009–2026.

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.

1,077
reports naming it as manufacturer: 0% of all MAUDE reports; 238
reports, 12 months to August 2026: 29 in the 12 months before; 7.1%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

1,077 medical device reports received by FDA give Caldera Medical as the manufacturer of the device involved, 0% of the MAUDE database, from May 2009 to July 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

238 reports arrived in the 12 months to August 2026, up 721% from 29 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 (91%), malfunction (7.1%) and other (1.8%). 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
Desara	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	292	0	0%
Tvt Exact Retropubic System	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	55	49	0%
T-Sling	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling	28	0	0%
Tension Free Vaginal Tape - Exact Unknown Product	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	28	28	0%
Tension Free Vaginal Tape Unknown Product	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	24	24	0%
Gynecare Tvt Obturator	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	17	15	0%
Gynecare Tvt Obturator W Lasr	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	14	14	0%
Tension Free Vaginal Tape - Obturator Unknown Prod	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	5	5	0%
Gynecare Tvt-Abbrevo Mini Lcm	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	4	4	0%
Gynecare TVT	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	2	3	0%

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
FTL	Mesh, surgical, polymeric	560	52%
OTN	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator	432	40.1%
PAH	Mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling	44	4.1%
OTO	Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed	19	1.8%
FTM	Mesh, surgical	10	0.9%
HIH	Hysteroscope (and accessories)	4	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

Death0%0

Injury91%980

Malfunction7.1%77

Other1.8%19

Not given0.1%1

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

Questions about Caldera Medical reports

How many FDA device reports name Caldera Medical as manufacturer?

1,077 reports through August 2026, 238 of them in the latest 12 months.

Which of its brands appear most often?

Desara (292), Tvt Exact Retropubic System (55), T-Sling (28), Tension Free Vaginal Tape - Exact Unknown Product (28) and Tension Free Vaginal Tape Unknown Product (24).

Which device types does it report on?

mesh, surgical, polymeric (52%), mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator (40.1%), mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling (4.1%) and mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed (1.8%).

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.