MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-10-31 for GORE-TEX SUTURE CV7 WLG607 0N07A manufactured by W.l. Gore & Associates.
[960968]
The physician called gore and reported he has a male patient that underwent ventral hernia repair in 2007. The surgeon claims the patient has 2 suture abscesses (right upper quadrant & lower left quadrant). The physician reported the patient was put on antibiotic therapy for a period of time, and the abscess in the right upper quadrant healed. However, the lower left quadrant abscess is flourishing. The physician reported that as he debrided the wound, short of the fascia, he could see the abscess tract, and drained the abscess. Additionally, he mentioned he has not cultured in a while. The physician reported, the patient is at home, and is being treated by his wife repacking the wound. Lot number info is not currently available by being requested.
Patient Sequence No: 1, Text Type: D, B5
[8211278]
Investigation is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003910212-2008-00044 |
| MDR Report Key | 1222020 |
| Report Source | 07 |
| Date Received | 2008-10-31 |
| Date of Report | 2008-10-31 |
| Date of Event | 2008-10-02 |
| Date Mfgr Received | 2008-10-02 |
| Date Added to Maude | 2008-11-14 |
| 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 | CRAIG BEARCHELL |
| Manufacturer Street | 301 AIRPORT RD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 9285263030 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE-TEX SUTURE CV7 |
| Generic Name | NONE |
| Product Code | NBY |
| Date Received | 2008-10-31 |
| Model Number | WLG607 |
| Catalog Number | 0N07A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1276294 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | ELKTON MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-31 |