MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2014-03-31 for GYNECARE PROFIX FASTENER SYSTEM PFRF01 manufactured by Ethicon Inc..
[4236026]
It was reported by an attorney that a patient underwent a gynecological procedure for pelvic floor repair and reduction of an enterocele in (b)(6) 2007 and fasteners were used to secure mesh. In (b)(6) 2007, stitch material was palpable in the vaginal wall. The patient experienced urinary urgency, urge incontinence, difficulty urinating, and pain in the lower abdomen and on the left side. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[11725825]
(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2014-04042 |
| MDR Report Key | 3715126 |
| Report Source | 00,01,07 |
| Date Received | 2014-03-31 |
| Date of Report | 2014-02-20 |
| Date Mfgr Received | 2014-03-04 |
| Device Manufacturer Date | 2006-05-31 |
| Date Added to Maude | 2014-03-31 |
| 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 | 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 | 2014-03-31 |
| Catalog Number | PFRF01 |
| Lot Number | 2921031 |
| Device Expiration Date | 2007-04-30 |
| 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 | 1. Required No Informationntervention | 2014-03-31 |