MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-06 for PRESOURCE CUSTOM STERILE DELIVERY PACK * manufactured by Cardinal Health.
[384445]
Ob patient had to have doctor return to room to remove a sponge inadvertently left in during delivery. Sponge and clot removed without problem. Physician involved resident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 560907 |
| MDR Report Key | 560907 |
| Date Received | 2004-12-06 |
| Date of Report | 2004-12-06 |
| Date of Event | 2004-11-05 |
| Report Date | 2004-12-06 |
| Date Reported to FDA | 2004-12-06 |
| Date Added to Maude | 2004-12-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESOURCE CUSTOM STERILE DELIVERY PACK |
| Generic Name | SURGICAL SPONGE |
| Product Code | MLS |
| Date Received | 2004-12-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 550615 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MEDICAL PRODUCTS SERVICES 1430 WAUKEGAN ROAD MCGAW PARK IL 600856787 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-06 |