MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-10-21 for FILSHIE AVM-851 manufactured by Femcare-nikomed.
[1304450]
During a tubal ligation, the filshie clip fell off the applicator. The clip was retrieved from the patient.
Patient Sequence No: 1, Text Type: D, B5
[8359139]
The subject clips were forwarded to femcare-nikomed, the manufacturer. This report will be amended as appropriate, once results of the manufacturer's investigation are known. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2009-00029 |
| MDR Report Key | 1516810 |
| Report Source | 08 |
| Date Received | 2009-10-21 |
| Date of Report | 2009-10-21 |
| Date of Event | 2009-09-30 |
| Date Mfgr Received | 2009-10-05 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2010-08-18 |
| 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 OCCLUSION |
| Product Code | HGB |
| Date Received | 2009-10-21 |
| Returned To Mfg | 2009-10-13 |
| Model Number | AVM-851 |
| Lot Number | 22561 |
| Device Expiration Date | 2011-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2009-10-21 |