MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-07 for BIOFRAGMENTABLE ANASTOMOSIS RING 8090-00 manufactured by Davis & Geck.
[15852]
Pt was originally admitted with diagnosis of diverticulosis. She underwent surgery on 6/14/95 where the bar was implanted. Shortly after her hosp discharge some 5 days post-op she began to complain of abdominal pain. She was readmitted and had a second operation on 6/25/95 where the bar was removed and noted to be fragmented.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 23623 |
| MDR Report Key | 23623 |
| Date Received | 1995-07-07 |
| Date of Report | 1995-07-03 |
| Date of Event | 1995-06-25 |
| Date Facility Aware | 1995-06-28 |
| Report Date | 1995-07-03 |
| Date Added to Maude | 1995-07-24 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOFRAGMENTABLE ANASTOMOSIS RING |
| Generic Name | RING |
| Product Code | LNN |
| Date Received | 1995-07-07 |
| Model Number | 8090-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 23920 |
| Manufacturer | DAVIS & GECK |
| Manufacturer Address | WAYNE NJ 07470 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1995-07-07 |