UNKNOWN Adverse Event — Injury (MDR 3003604053-2020-00028)
UNKNOWN Adverse Event — Injury (MDR 3003604053-2020-00028) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: UNKNOWN; Generic name: STAPLE, IMPLANTABLE; Manufacturer: SMITH & NEPHEW, INC..
| Device | UNKNOWN |
|---|---|
| Generic name | STAPLE, IMPLANTABLE |
| Manufacturer | SMITH & NEPHEW, INC. |
| Report number | 3003604053-2020-00028 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | H3, H6: LOT NUMBER INFORMATION IS NOT PROVIDED AND NO ADDITIONAL INFORMATION WAS RECEIVED FOR DOCUMENTATION REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED, THE DOCUMENTATION REVIEW WILL BE REVISITED. WITH THE PROVIDED INFORMATION, SMITH AND NEPHEW IS UNABLE TO DETERMINE IF DEVICE MET MANUFACTURING SPECIFICATIONS. SEVERAL COMPLAINTS RELATED TO INFLAMMATION POST PROCEDURE WITH SCAFFOLD HAVE BEEN OBSE |
| Source | openFDA MAUDE (device adverse events) |
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