MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1999-07-01 for CODMAN SURGICAL PATTIE UNK manufactured by Johnson & Johnson Professional, Inc..
[140118]
Intl customer reports suspicion of surgical patties leading to pt infection. The patties are reported to have appeared with spots while still in closed sterile packs that were stored under questionable conditions for a period of up to many years. Multiple lots have been reported but the product code(s) not identified. The event has not been related to an isolated product or lot code to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219655-1999-00116 |
| MDR Report Key | 229735 |
| Report Source | 01,07 |
| Date Received | 1999-07-01 |
| Date of Report | 1999-07-01 |
| Date Mfgr Received | 1999-06-08 |
| Date Added to Maude | 1999-07-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN SURGICAL PATTIE |
| Generic Name | SURGIAL SPONGE |
| Product Code | GER |
| Date Received | 1999-07-01 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 222804 |
| Manufacturer | JOHNSON & JOHNSON PROFESSIONAL, INC. |
| Manufacturer Address | 15 COMMERCE WAY NORTON MA 02766 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-07-01 |