MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2015-06-03 for GYNECARE PROFIX FASTENER SYSTEM PFRF01 manufactured by Ethicon Inc..
[5832054]
It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and a mesh was implanted. It was reported that the patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. It was reported that the patient has undergone multiple surgeries and revisionary procedures. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[13387644]
(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
[24998514]
(b)(4). It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and a mesh was implanted. It was reported that patient underwent placement of a permanent implantable programmable generator sns (interstim) stage 1 due to urinary retention on (b)(6) 2009 and sns stage 2 on (b)(6) 2009. No additional information was provided.
Patient Sequence No: 1, Text Type: N, H10
[26970314]
It was reported that patient underwent and laparoscopic lysis of adhesions and a intraoperative transgastric remnant gastroscopy on (b)(6) 2013.
Patient Sequence No: 1, Text Type: N, H10
[53046058]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2015-06648 |
| MDR Report Key | 4815271 |
| Report Source | 00,OTHER |
| Date Received | 2015-06-03 |
| Date of Report | 2016-08-05 |
| Date Mfgr Received | 2016-08-05 |
| Device Manufacturer Date | 2005-11-23 |
| Date Added to Maude | 2015-06-03 |
| 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 | 3 |
| Event Location | 3 |
| 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 | ETHICON SARL-NEUCHATEL |
| Manufacturer Street | PUITS-GODET 20 2000 NEUCHATEL |
| Manufacturer City | NEUCHATEL |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE PROFIX FASTENER SYSTEM |
| Generic Name | IMPLANTABLE STAPLE, NONABSORBABLE |
| Product Code | PBQ |
| Date Received | 2015-06-03 |
| Catalog Number | PFRF01 |
| Lot Number | 1365867 |
| Device Expiration Date | 2006-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-03 |