PROLENE BL 6-0 60 CM CC-11(2) Adverse Event — Malfunction (MDR 2210968-2020-03514)
PROLENE BL 6-0 60 CM CC-11(2) Adverse Event — Malfunction (MDR 2210968-2020-03514) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROLENE BL 6-0 60 CM CC-11(2); Generic name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE; Manufacturer: ETHICON INC..
| Device | PROLENE BL 6-0 60 CM CC-11(2) |
|---|---|
| Generic name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
| Manufacturer | ETHICON INC. |
| Report number | 2210968-2020-03514 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. A PICTURE WAS RECEIVED FOR ANALYSIS. UPON VISUAL INSPECTION OF THE PICTURE, THE FOLL |
| Source | openFDA MAUDE (device adverse events) |
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