MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-04-27 for COATED VICRYL (POLYGLACTIN 910) SUTURE UNK manufactured by Ethicon, Inc., San Angelo.
[222943]
It was reported the sutures were use in a hybrid total right hip arthroplasty in 2001. Patient returned to physician complaining of burning over the site of the incision. Patient presented with drainage from the incision site and difficulty standing from a seated position. Patient re-admitted 2 months later and was re-operated for drainage of the incision and placed on iv antibiotics. Patient was discharged 5 days later and remained on iv antibiotics. Suture removal was scheduled for 13 days post re-operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2001-00191 |
| MDR Report Key | 329328 |
| Report Source | 05,06 |
| Date Received | 2001-04-27 |
| Date of Report | 2001-03-28 |
| Date of Event | 2001-03-22 |
| Date Facility Aware | 2001-03-22 |
| Report Date | 2001-03-28 |
| Date Mfgr Received | 2001-03-28 |
| Date Added to Maude | 2001-05-01 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BERKLEY POLLARD |
| Manufacturer Street | ROUTE 22 WEST PO 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 | GHM |
| Date Received | 2001-04-27 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 318697 |
| 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 | 2001-04-27 |