MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-01-06 for FILSHIE AVM-863 manufactured by Femcare-nikomed.
[19964522]
During a tubal ligation, the jaw broke off the filshie applicator and had to be retrieved from the patient.
Patient Sequence No: 1, Text Type: D, B5
[20110676]
The subject applicator was purchased by the user facility in july 2006. The manufacturer recommends the applicator be serviced every 100 uses or yearly which ever comes first. Records indicate the applicator has not been sent in for service since purchased. The user facility has indicated the applicator will be returned for evaluation, however, as of this report the applicator has not be received. Upon receipt of the subject applicator, (the distributor) will forward the applicator to femcare-nikomed (the manufacturer) for evaluation. This report will be supplemented as appropriate upon conclusion of femcare-nikomed's investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2008-00044 |
| MDR Report Key | 1304003 |
| Report Source | 06 |
| Date Received | 2009-01-06 |
| Date of Report | 2009-01-06 |
| Date of Event | 2008-12-15 |
| Date Mfgr Received | 2008-12-15 |
| Date Added to Maude | 2009-07-14 |
| 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 | TUBAL OCCLUSION |
| Product Code | HGB |
| Date Received | 2009-01-06 |
| Model Number | AVM-863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FEMCARE-NIKOMED |
| Manufacturer Address | ROMSEY, HAMPSHIRE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-06 |