MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-01-28 for PDS II (POLYDIOXANONE) SUTURE UNK manufactured by Ethicon, Inc..
[392468]
Customer reported that the suture broke at an unspecified time following surgery. Pt was taken to the o. R. For surgical repair. No further info provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2005-00041 |
| MDR Report Key | 568603 |
| Report Source | 06 |
| Date Received | 2005-01-28 |
| Date of Report | 2005-01-03 |
| Report Date | 2005-01-03 |
| Date Mfgr Received | 2005-01-03 |
| Date Added to Maude | 2005-01-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARK YALE |
| Manufacturer Street | P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182326 |
| Manufacturer G1 | ETHICON INC., SAN ANGELO |
| Manufacturer Street | 3348 PULLIAM STREET |
| Manufacturer City | SAN ANGELO TX * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PDS II (POLYDIOXANONE) SUTURE |
| Generic Name | SUTURE, ABSORBABLE |
| Product Code | GNH |
| Date Received | 2005-01-28 |
| 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 | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 558432 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST P.O. BOX 151 SOMERVILLE NJ 088760151 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-01-28 |