MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE manufactured by Covidien.
[184658625]
Raytek sponges that have been falling apart during cases. Pieces of raytek are being found during the case in the patient and surgeons are having to pick out the "stringy" pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9871490 |
| MDR Report Key | 9871490 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-11 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-24 |
| Date Added to Maude | 2020-03-24 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE |
| Product Code | GDY |
| Date Received | 2020-03-24 |
| Lot Number | 19M014862 AND 19L134862 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 5920 LONGBOW DRIVE BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |