MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-04 for PEANUT SPONGE * 30-106 manufactured by Deroyal.
[5795665]
Surgeon was using peanut sponge and noted small speck of radiopaque blue fiber separated from the sponge and was in the incision. The surgeon was able to retrieve the fiber but was concerned and requested follow up regarding contamination of surgical incision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4764952 |
| MDR Report Key | 4764952 |
| Date Received | 2015-05-04 |
| Date of Report | 2015-05-04 |
| Date of Event | 2014-10-13 |
| Report Date | 2015-05-04 |
| Date Reported to FDA | 2015-05-04 |
| Date Reported to Mfgr | 2015-05-12 |
| Date Added to Maude | 2015-05-12 |
| 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 | PEANUT SPONGE |
| Generic Name | SPONGE |
| Product Code | GDI |
| Date Received | 2015-05-04 |
| Model Number | * |
| Catalog Number | 30-106 |
| Lot Number | 36698674 |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-04 |