MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-04 for BREAST RETRACTOR (LIGHTED) 110-688LS manufactured by Marina Medical.
| Report Number | 9005892 |
| MDR Report Key | 9005892 |
| Date Received | 2019-09-04 |
| Date of Report | 2019-08-30 |
| Date of Event | 2019-08-26 |
| Date Facility Aware | 2019-08-26 |
| Report Date | 2019-08-30 |
| Date Added to Maude | 2019-09-12 |
| 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 | 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 | 0 |
| Brand Name | BREAST RETRACTOR (LIGHTED) |
| Generic Name | BREAST RETRACTOR (LIGHTED) |
| Product Code | GAD |
| Date Received | 2019-09-04 |
| Model Number | 110-688LS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARINA MEDICAL |
| Manufacturer Address | DAVIE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-04 |