CATGUT PLAIN 2-0 70CM (1)MH Adverse Event — Malfunction (MDR 2210968-2020-03552)
CATGUT PLAIN 2-0 70CM (1)MH Adverse Event — Malfunction (MDR 2210968-2020-03552) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CATGUT PLAIN 2-0 70CM (1)MH; Generic name: SUTURE, ABSORBABLE, NATURAL; Manufacturer: ETHICON INC..
| Device | CATGUT PLAIN 2-0 70CM (1)MH |
|---|---|
| Generic name | SUTURE, ABSORBABLE, NATURAL |
| Manufacturer | ETHICON INC. |
| Report number | 2210968-2020-03552 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AL9590 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. SUMMARY: TWO PICTURES WERE RECEIVED FOR ANALYSIS. UPON VISUAL INSPECTION OF THE PICTURES, THE FOLLOWING WAS OBSERVED. THE FIRST PICTURE SHOWS AN UNOPENED SAMPLE OF PRODUCT CODE (B)(4), THE LOT NUMBER IS NOT VISIBLE. THE SECOND SAMPLE SHOW A HOLDER WITH A DETACHED |
| Source | openFDA MAUDE (device adverse events) |
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