MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-23 for SURGIFISH VISCERA RETAINER UNK manufactured by Greer Medical Inc.
[4556762]
My husband (b)(6) had a surgifish viscera retainer left inside his abdomen for 12 days by mistake during his first surgery on (b)(6), 2014, for aorta bifemoral bypass. He had to have an emergency operation on (b)(6), 2014 to remove the surgifish viscera retainer and he remains in critical condition in the icu at (b)(6), and today is (b)(6), 2014. (b)(6) has all the records, charts and medical mishap reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037440 |
| MDR Report Key | 3961139 |
| Date Received | 2014-07-23 |
| Date of Report | 2014-07-22 |
| Date of Event | 2014-07-07 |
| Date Added to Maude | 2014-07-29 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIFISH VISCERA RETAINER |
| Generic Name | VISCERA RETAINER |
| Product Code | GCZ |
| Date Received | 2014-07-23 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Expiration Date | 2014-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREER MEDICAL INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2014-07-23 |