MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-02 for GREER SURGIFISH VISCERA RETAINER 4001 manufactured by Greer Medical Inc..
[40723928]
Surgifish left in abdomen during closure of skin in abdominal surgery for (exploratory laparotomy duodenotomy, excision of lesion).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5508213 |
| MDR Report Key | 5508213 |
| Date Received | 2005-02-02 |
| Date of Report | 2005-02-02 |
| Date of Event | 2004-12-15 |
| Date Facility Aware | 2005-01-18 |
| Report Date | 2005-02-02 |
| Date Reported to FDA | 2005-02-02 |
| Date Added to Maude | 2016-03-17 |
| 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 | GREER SURGIFISH VISCERA RETAINER |
| Generic Name | OPERATING ROOM VISCERA RETAINER |
| Product Code | GCZ |
| Date Received | 2005-02-02 |
| Model Number | 4001 |
| Lot Number | 082404 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREER MEDICAL INC. |
| Manufacturer Address | 314 EAST CARRILLO ST. SANTA BARBARA CA 93101 US 93101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-02-02 |