MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2014-03-10 for MERSILENE POLYESTER FIBER SUTURE UNK manufactured by Ethicon Inc..
[15103559]
It was reported by the patient that she underwent a procedure on and unknown date and suture was used. She stated that post operatively she developed nerve damage causing facial drooping. The patient underwent an open head and neck re-exploration, in which the surgeon removed the suture previously implanted. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[15334037]
(b)(4). No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2014-02030 |
| MDR Report Key | 3670662 |
| Report Source | 04,05 |
| Date Received | 2014-03-10 |
| Date of Report | 2014-02-13 |
| Date Mfgr Received | 2014-02-13 |
| Date Added to Maude | 2014-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GUILLERMO VILLA |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Manufacturer G1 | UNKNOWN |
| Manufacturer Street | UNKNOWN |
| Manufacturer City | X |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERSILENE POLYESTER FIBER SUTURE |
| Generic Name | SUTURE NON ABSORBABLE |
| Product Code | GAS |
| Date Received | 2014-03-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876015 US 08876 0151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-10 |