Device manufacturer, as written on reports

Kenstone Metal: medical device reports filed with FDA

1,261 reports name it as the manufacturer of the device involved, 2010–2015.

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.

1,261
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 12.4%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

1,261 medical device reports received by FDA give Kenstone Metal as the manufacturer of the device involved, 0% of the MAUDE database, from May 2010 to May 2015. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and none 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 (12.4%), injury (1%) and other (0.2%). 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	Classified as death
Mechanical Walker Rollator	Walker, mechanical	690	0%
Daily Activity Assist Devices	Aid, transfer	302	0%
Mechanical Chair/Transport Chair	Chair, with casters	75	0.2%
Mechanical Manual Wheelchair	Wheelchair, mechanical	25	0%
Cane Crutch And Walker Tips And Pads	Tips and pads, cane, crutch and walker	12	0%
Rollator 9153651315	Walker, mechanical	6	0%
Economy Rollator W/Hand Brake W/Curve Bkrst 9153644547	Walker, mechanical	5	0%
Powered Wheelchair	Wheelchair, powered	3	0.1%
Tracer Transport Chair 19 X 16 9153647029	Wheelchair, mechanical	1	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
ITJ	Walker, mechanical	800	63.4%
IKX	Aid, transfer	251	19.9%
INM	Chair, with casters	78	6.2%
ILS	Adaptor, hygiene	70	5.6%
IOR	Wheelchair, mechanical	37	2.9%
INP	Tips and pads, cane, crutch and walker	13	1%
INN	Chair, adjustable, mechanical	4	0.3%
ITI	Wheelchair, powered	3	0.2%
FNL	Bed, ac-powered adjustable hospital	1	0.1%

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

Injury1%12

Malfunction12.4%156

Other0.2%2

Not given86.5%1,091

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

Questions about Kenstone Metal reports

How many FDA device reports name Kenstone Metal as manufacturer?

1,261 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Mechanical Walker Rollator (690), Daily Activity Assist Devices (302), Mechanical Chair/Transport Chair (75), Mechanical Manual Wheelchair (25) and Cane Crutch And Walker Tips And Pads (12).

Which device types does it report on?

walker, mechanical (63.4%), aid, transfer (19.9%), chair, with casters (6.2%) and adaptor, hygiene (5.6%).

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.