MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-07-23 for FILSHIE AVM-856 manufactured by Femcare-nikomed.
[884701]
During a tubal ligation, the hinge of the filshie applicator broke while in the patient. A small piece of the hinge was not found. The tip was retrieved.
Patient Sequence No: 1, Text Type: D, B5
[8073391]
The user facility purchased the applicator in 2006. Femcare-nikomed, the mfr, recommends the applicator is serviced every 100 uses or yearly which ever comes first. The applicator has not been serviced since purchased. As of this report, the user facility has not yet returned the applicator. This report will be supplemented as appropriate upon receipt of the applicator and the conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2008-00022 |
| MDR Report Key | 1082592 |
| Report Source | 06 |
| Date Received | 2008-07-23 |
| Date of Report | 2008-07-23 |
| Date of Event | 2008-06-27 |
| Date Mfgr Received | 2008-06-27 |
| Date Added to Maude | 2008-10-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILSHIE |
| Generic Name | CLIP, TUBAL OCCULSION |
| Product Code | HGB |
| Date Received | 2008-07-23 |
| Model Number | AVM-856 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1223546 |
| Manufacturer | FEMCARE-NIKOMED |
| Manufacturer Address | ROMSEY, HEMPSHIRE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-23 |