MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-09-19 for FILSHIE AVM-851 * manufactured by Femcare-nikomed.
[8004327]
The catalog number for the filshie clip is avm-851. The lot info is not available. The filshie clips are lot controlled, however the facility where the original application of the filshie clips has not been identified, no determination of possible lot numbers that may have been used cannot be made. Filshie clips effect sterilization by causing necrosis at the site of application. Subsequently, the clips are held in place by covering peritoneum. If this process is delayed, clip migration may result. Low grade inflammation may occur if displacement occurs. Both silicone and titanium have been well established as implant material.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2007-00024 |
| MDR Report Key | 1032091 |
| Report Source | 00 |
| Date Received | 2007-09-19 |
| Date Mfgr Received | 2007-09-04 |
| Date Added to Maude | 2008-04-23 |
| 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 | 3 |
| 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 | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2007-09-19 |
| Model Number | AVM-851 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 999373 |
| Manufacturer | FEMCARE-NIKOMED |
| Manufacturer Address | * NOTTINGHAM UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-19 |