MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-20 for LAP SPONGE UNKNOWN manufactured by Unknown.
[22883]
Retained lap sponge. Required reexploration of abdomen. Discovered on post-procedure x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33955 |
| MDR Report Key | 33955 |
| Date Received | 1996-05-20 |
| Date of Report | 1996-05-20 |
| Date of Event | 1996-05-07 |
| Date Facility Aware | 1996-05-07 |
| Report Date | 1996-05-20 |
| Date Added to Maude | 1996-07-10 |
| 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 |
| 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 | LAP SPONGE |
| Generic Name | LAP SPONGE |
| Product Code | GOY |
| Date Received | 1996-05-20 |
| Model Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 35296 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-05-20 |