MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-07-29 for LAP SAC UNK manufactured by Cook Urological, Inc..
[323113]
The doctor performed a nephrectomy. He had failed to remove the bag before closing the incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825146-2003-00008 |
| MDR Report Key | 474649 |
| Report Source | 00 |
| Date Received | 2003-07-29 |
| Date Mfgr Received | 2003-07-10 |
| Date Added to Maude | 2003-08-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1100 WEST MORGAN STREET |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 3128294891 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAP SAC |
| Generic Name | SURGICAL TISSUE POUCH |
| Product Code | KGY |
| Date Received | 2003-07-29 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 463512 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | 1100 WEST MORGAN ST. SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-29 |