MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-11 for LAP CHOLE PACK 910726 SBA45LCNCD manufactured by Cardinal Health.
[15445805]
Particles of dirt or?? Found inside 7 quart blue ring basins part of lap chole pack. Two separate incidents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034650 |
| MDR Report Key | 574691 |
| Date Received | 2005-02-11 |
| Date of Report | 2005-02-11 |
| Date of Event | 2004-02-03 |
| Date Added to Maude | 2005-02-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAP CHOLE PACK |
| Generic Name | 7 QUART BLUE RING BASIN |
| Product Code | FNY |
| Date Received | 2005-02-11 |
| Model Number | 910726 |
| Catalog Number | SBA45LCNCD |
| Lot Number | * |
| ID Number | MFG DATE: 11/19/20 |
| Device Expiration Date | 2006-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 564539 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-11 |