ULTRA COMFORT, SE 4 X 30 INTL Adverse Event — Malfunction (MDR 0001831750-2020-00434)
ULTRA COMFORT, SE 4 X 30 INTL Adverse Event — Malfunction (MDR 0001831750-2020-00434) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ULTRA COMFORT, SE 4 X 30 INTL; Generic name: MATTRESS, FLOTATION THERAPY, NON-POWERED; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | ULTRA COMFORT, SE 4 X 30 INTL |
|---|---|
| Generic name | MATTRESS, FLOTATION THERAPY, NON-POWERED |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00434 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICES WERE NOT EVALUATED AND NO CAUSE WAS DETERMINED, AS THE CUSTOMER DID NOT MAKE THE DEVICES ACCESSIBLE FOR TESTING. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE. |
| Source | openFDA MAUDE (device adverse events) |
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