Adaptor, hygiene: medical device reports filed with FDA

4,668 reports carry this product code, 1995–2026; 10 brands with a page.

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.

4,668
reports with this product code: 0% of all MAUDE reports; 1,782
reports, 12 months to August 2026: 39 in the 12 months before; 82.4%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code ILS is FDA's classification for "Adaptor, hygiene" (physical Medicine panel), a class 1 device. 4,668 medical device reports carry this product code, 0% of the MAUDE database, from August 1995 to August 2026.

1,782 reports arrived in the 12 months to August 2026, up 4469% from 39 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 malfunction (82.4%), injury (9%) and other (0.3%). 10 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Daily Activity Assist Devices	1,054	0	0%	36.9%
All-In-One Commode Coated 9153629773	289	0	0%	99.7%
All-In-One Commode 9153629772	272	0	0%	100%
Drive	134	20	4.4%	13.1%
Guardian	110	350	0.4%	72.2%
Drive Medical	12	0	10%	5.2%
Equate	9	37	0.3%	24%
Alenti	2	9	5.4%	56%
Communicator	1	0	0%	98.8%
Tdxsp Electric Red Euro Wide Base W/ 23-1 Ssd Gear Box	1	0	0.2%	98.9%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medline Industries	1,734	37.1%
Invamex	870	18.6%
Invacare Taylor Street	108	2.3%
Kenstone Metal	70	1.5%
Invacare	13	0.3%
Arjo Hospital Equipment	7	0.1%
Arjohuntleigh Polska Sp Z O O	2	0%
Danyang Maxthai Medical Equipment	1	0%
Icu Medical	1	0%
Invacare Rehabilitation Equip	1	0%
Wilson-Cook Medical	1	0%

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 and report source

Event type

Death0.2%10

Injury9%421

Malfunction82.4%3,847

Other0.3%15

Not given8%375

Who filed

Manufacturer report85.2%3,975

Voluntary report1.1%50

User facility report0%0

Distributor report13.2%614

Not given0.6%29

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Crackthe device cracked	1,149	24.6%
Material twisted/bent	798	17.1%
Breakthe device broke	657	14.1%
Fracturea broken bone	450	9.6%
Unstable	338	7.2%
Bent	255	5.5%
Loose or intermittent connection	167	3.6%
Collapse	103	2.2%
Component missing	84	1.8%
Device operates differently than expectedthe device behaved unexpectedly	69	1.5%
Product quality problem	69	1.5%
Out-of-box failure	67	1.4%
Detachment of device component	66	1.4%
Material integrity problema problem with the device material	61	1.3%
Detachment of device or device componentpart of the device came off	53	1.1%
Mechanical problema mechanical problem	45	1%
Device slipped	41	0.9%
Insufficient device problem information	39	0.8%
Mechanical jam	34	0.7%
Activation problem	30	0.6%

Questions about adaptor, hygiene reports

What is product code ILS?

FDA's classification code for "Adaptor, hygiene", class 1, reviewed by the physical Medicine panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,668 reports through August 2026, 1,782 of them in the latest 12 months.

Which brands appear most often?

Daily Activity Assist Devices (1,054), All-In-One Commode Coated 9153629773 (289), All-In-One Commode 9153629772 (272), Drive (134) and Guardian (110). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.