Devices › Lift, patient, non-ac-powered
Device brand name · Hearing aid
Opera: medical device reports filed with FDA
202 reports name it, 1997–2018. Manufacturer given most often on reports: Arjo Med. Product code FSA.
- 202
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 62.4%
- classified as malfunction
- 67.8% across the product code
- 2.5%
- classified as death, as reported
- 5 reports · not verified by FDA
202 medical device reports received by FDA name the brand "Opera" (hearing aid); the manufacturer given most often on reports is Arjo Med; received from September 1997 to November 2018. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (62.4%), injury (31.2%) and other (3.5%); across all lift, patient, non-ac-powered reports (product code FSA) death is recorded in 2.8% and malfunction in 67.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device component (9.9%), component falling (9.4%) and detachment of device or device component (3.5%). The patient problems coded most often are fall, bruise/contusion and bleeding. 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."
Reports by month, five years
No report naming Opera was received in the five years to August 2026; the latest was received in November 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 15,182 reports carrying product code FSA. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Detachment of device component | 20 | 9.9% | 8.2% |
| Component falling | 19 | 9.4% | 3% |
| Detachment of device or device componentpart of the device came off | 7 | 3.5% | 6.6% |
| Breakthe device broke | 6 | 3% | 11.5% |
| Source, detachment from | 6 | 3% | 0.3% |
| Material separation | 5 | 2.5% | 1.8% |
| Component(s), worn | 3 | 1.5% | 0.1% |
| Device tipped over | 3 | 1.5% | 4.7% |
| Reactiona reaction, type not specified | 3 | 1.5% | 0% |
| Device slipped | 2 | 1% | 3.1% |
| Difficult to position | 2 | 1% | 0.1% |
| Fracturea broken bone | 2 | 1% | 1.3% |
| Insufficient device problem information | 2 | 1% | 2.3% |
| Other (for use when an appropriate device code cannot be identified) | 2 | 1% | 0.6% |
| Sparking | 2 | 1% | 0.3% |
| Unintended arm motion | 2 | 1% | 0% |
| Component missing | 1 | 0.5% | 0.9% |
| Defective component | 1 | 0.5% | 0.4% |
| Design/structure problem | 1 | 0.5% | 0.2% |
| Device emits odor | 1 | 0.5% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Falla fall | 8 | 4% |
| Bruise/contusion | 7 | 3.5% |
| Bleeding | 6 | 3% |
| Foreign body, removal of | 6 | 3% |
| Other (for use when an appropriate patient code cannot be identified) | 5 | 2.5% |
| Blister(s) | 4 | 2% |
| Laceration(s) | 4 | 2% |
| Painpain, site not specified | 4 | 2% |
| Bone fracture(s) | 3 | 1.5% |
| Deaththe patient died; cause not stated by this term | 3 | 1.5% |
| Discomfortdiscomfort | 3 | 1.5% |
| Soreness | 3 | 1.5% |
| Therapy/non-surgical treatment, additional | 3 | 1.5% |
| Burn(s)a burn | 2 | 1% |
| Dural tear | 2 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Opera | Product code FSA | All MAUDE reports |
|---|---|---|---|
| Reports | 202 | 15,182 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 25 | 28 | 9 |
| Classified as injury | 31.2% | 18.8% | 36.2% |
| Classified as malfunction | 62.4% | 67.8% | 62.3% |
| Filed by the manufacturer | 95.5% | 87.4% | 94.9% |
Shares are of reports, not 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."
Other brands with product code FSA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Non Ac-Powered Patient Lift | 2,668 | 0 | 0.3% |
| Maxi Move | 785 | 26 | 3.6% |
| Alenti | 277 | 9 | 5.4% |
| Sara 3000 | 278 | 8 | 4% |
| Power Lift W/Low Base-Plus 9153633519 | 239 | 0 | 2.1% |
| Hydraulic Lift W/Adj Base Beige Powdercoat 9153644679 | 214 | 0 | 0.5% |
| Maxilift | 226 | 0 | 2.2% |
| Maxi Twin | 192 | 17 | 6.3% |
| Hydraulic Lift W/Adj Base 9153629360 | 182 | 0 | 0% |
| Hoyer Lift | 260 | 0 | 2.7% |
| Marisa | 186 | 0 | 4.8% |
| Hydraulic Lift W/Low Base-Plus 9153633521 | 161 | 0 | 0% |
| Maxi Sky 600 | 188 | 7 | 2.7% |
| Golvo | 159 | 0 | 4.4% |
| Maxi Sky 2 | 151 | 21 | 5.3% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Opera reports
How many FDA reports name Opera?
202 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (62.4%), injury (31.2%) and other (3.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device component (9.9%), component falling (9.4%), detachment of device or device component (3.5%), break (3%) and source, detachment from (3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (95.5%) and distributor reports (4.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Opera was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.