MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-11-09 for COATED VICRYL (POLYGLACTIN 910) SUTURE UNK manufactured by Ethicon, Inc. San Angelo.
[20684374]
It was reported by the attorney that the plaintiff had a medtronic pump implant in 1998. In the course of the surgery, vicryl sutures were used. It was alleged by the attorney that the vicryl sutures used were contaminated, thus not sterile, thereby causing the plaintiff to suffer infection and injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2000-00446 |
| MDR Report Key | 303830 |
| Report Source | 00 |
| Date Received | 2000-11-09 |
| Date of Report | 2000-10-12 |
| Date of Event | 1998-01-01 |
| Report Date | 2000-10-12 |
| Date Mfgr Received | 2000-10-12 |
| Date Added to Maude | 2000-11-13 |
| 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 | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR BERKLEY POLLARD |
| Manufacturer Street | P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182005 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COATED VICRYL (POLYGLACTIN 910) SUTURE |
| Generic Name | SUTURE, ABSORBABLE |
| Product Code | HAM |
| Date Received | 2000-11-09 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 294047 |
| Manufacturer | ETHICON, INC. SAN ANGELO |
| Manufacturer Address | 3348 PULLIAM STREET SAN ANGELO TX 769054403 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-11-09 |