MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-23 for FILSHIE CLIP * AVM-851J manufactured by Avalon Medical Corporation.
[17908562]
Surgical contraception clip would not lock at first. Then the device did lock but opened again. Another device was used and this one was retained for the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 590498 |
| MDR Report Key | 590498 |
| Date Received | 2005-03-23 |
| Date of Report | 2005-03-23 |
| Date of Event | 2005-03-15 |
| Report Date | 2005-03-23 |
| Date Reported to FDA | 2005-03-23 |
| Date Added to Maude | 2005-04-14 |
| 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 |
| 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 | FILSHIE CLIP |
| Generic Name | FEMALE SURGICAL CONTRACEPTION DEVICE |
| Product Code | HGB |
| Date Received | 2005-03-23 |
| Model Number | * |
| Catalog Number | AVM-851J |
| Lot Number | 01962 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 580349 |
| Manufacturer | AVALON MEDICAL CORPORATION |
| Manufacturer Address | 185 ALLEN BROOK LANE WILLISTON VT 05495 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-23 |