PROLENE SUTURE 36"(90CM) 4-0 BLU Adverse Event — Malfunction (MDR 2210968-2020-03342)
PROLENE SUTURE 36"(90CM) 4-0 BLU Adverse Event — Malfunction (MDR 2210968-2020-03342) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROLENE SUTURE 36"(90CM) 4-0 BLU; Generic name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE; Manufacturer: ETHICON INC..
| Device | PROLENE SUTURE 36"(90CM) 4-0 BLU |
|---|---|
| Generic name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE |
| Manufacturer | ETHICON INC. |
| Report number | 2210968-2020-03342 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT PLR970, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. INVESTIGATION SUMMARY: UNOPENED SAMPLES OF PRODUCT CODE 8521, LOT # PLR970 WERE RETURNED FOR EVALUATION. THE COMPLAINT SAMPLE WAS NOT RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF UNOPENED SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPE |
| Source | openFDA MAUDE (device adverse events) |
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