PRIME TC SWING-AWAY MODEL Adverse Event — Malfunction (MDR 0001831750-2020-00457)
PRIME TC SWING-AWAY MODEL Adverse Event — Malfunction (MDR 0001831750-2020-00457) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PRIME TC SWING-AWAY MODEL; Generic name: CHAIR, ADJUSTABLE, MECHANICAL; Manufacturer: STRYKER MEDICAL-KALAMAZOO.
| Device | PRIME TC SWING-AWAY MODEL |
|---|---|
| Generic name | CHAIR, ADJUSTABLE, MECHANICAL |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Report number | 0001831750-2020-00457 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICES WERE EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; 3 DEVICES HAD BROKEN/DAMAGED COMPONENTS, 1 DEVICE HAD A LOOSE COMPONENT, AND 1 DEVICE HAD A BENT COMPONENT. THE DEVICES WERE REPAIRED AND RETURNED. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FO |
| Source | openFDA MAUDE (device adverse events) |
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