SFX SYM PDS+ UNI VIO 18IN 0 S/A CTXB Adverse Event — Malfunction (MDR 2210968-2020-03523)
SFX SYM PDS+ UNI VIO 18IN 0 S/A CTXB Adverse Event — Malfunction (MDR 2210968-2020-03523) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SFX SYM PDS+ UNI VIO 18IN 0 S/A CTXB; Generic name: SUTURE, SURGICAL, ABSORBABLE; Manufacturer: ETHICON INC..
| Device | SFX SYM PDS+ UNI VIO 18IN 0 S/A CTXB |
|---|---|
| Generic name | SUTURE, SURGICAL, ABSORBABLE |
| Manufacturer | ETHICON INC. |
| Report number | 2210968-2020-03523 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | (B)(4). DATE SENT TO THE FDA: 06/08/2020. ONE OPEN SAMPLE WAS RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION OF UNUSED OPENED SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOT OBSERVED AS EXPECTED; SINCE THE HIT OF THE STAKE WAS NOT PRESENT AT THE SWAGE AREA OF NEEDLE; CAUSING THAT SUTURE WAS DETACHED FROM THE NEEDLE. IN ADDITION, THE SUTURE WAS EXAMINED, AND THE INSERTION END COULD NOT BE OBSER |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →