MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for SITUATE L1818-04P01C-1 manufactured by Covidien.
[177373994]
Laparotomy sponges lot #190201at. Sponges were opened to the field. When counting, a dark brown area was noted on one of the sponges. Product removed from field and tech removed contaminated gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659247 |
| MDR Report Key | 9659247 |
| Date Received | 2020-02-03 |
| Date of Report | 2019-11-07 |
| Date of Event | 2019-11-07 |
| Report Date | 2019-11-07 |
| Date Reported to FDA | 2019-11-07 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Brand Name | SITUATE |
| Generic Name | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE |
| Product Code | GDY |
| Date Received | 2020-02-03 |
| Model Number | L1818-04P01C-1 |
| Catalog Number | L1818-04P01C-1 |
| Lot Number | 190201AT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |