ETHILON II BLU 75CM M2 Adverse Event — Malfunction (MDR 2210968-2020-03507)
ETHILON II BLU 75CM M2 Adverse Event — Malfunction (MDR 2210968-2020-03507) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ETHILON II BLU 75CM M2; Generic name: SUTURE, NONABSORBABLE, SYNTHETIC; Manufacturer: ETHICON INC..
| Device | ETHILON II BLU 75CM M2 |
|---|---|
| Generic name | SUTURE, NONABSORBABLE, SYNTHETIC |
| Manufacturer | ETHICON INC. |
| Report number | 2210968-2020-03507 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). AN OPENED SAMPLE OF PRODUCT WAS RECEIVED FOR ANALYSIS. DURING VISUAL INSPECTION OF THE DETACHED NEEDLE, A SHORT SWAGE COULD BE OBSERVED RESULTING IN AN INCORRECT SWAGE. THIS CONDITION CAUSES THE NEEDLE TO BE DETACHED FROM THE SUTURE. THE SUTURE WAS EXAMINED ALONG THE STRAND AND THE END DAMAGED WAS NOTED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE |
| Source | openFDA MAUDE (device adverse events) |
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