COMFGEL SE W/O FIRE BAR, 30IN Adverse Event — Malfunction (MDR 0001831750-2020-00537)
COMFGEL SE W/O FIRE BAR, 30IN Adverse Event — Malfunction (MDR 0001831750-2020-00537) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COMFGEL SE W/O FIRE BAR, 30IN; Generic name: MATTRESS, FLOTATION THERAPY, NON-POWERED; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | COMFGEL SE W/O FIRE BAR, 30IN |
|---|---|
| Generic name | MATTRESS, FLOTATION THERAPY, NON-POWERED |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00537 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS NOT EVALUATED AND NO CAUSE WAS DETERMINED, AS THE CUSTOMER DID NOT MAKE THE DEVICE 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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