MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for FILSHIE CLIPS TWENTY PAIR STERILE FILSHIE CLIPS AVM-851 manufactured by Femcare Limited.
[174510139]
During tubal ligation, the filshie clip applicator was inserted and filshie clip was attempted to be deployed, but it would not lock on the tube. Three other filshie clips were tried and none of them would lock on the tube. Surgeon attempted to close and engage the clips outside the body, and they would not engage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9574379 |
| MDR Report Key | 9574379 |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-21 |
| Date of Event | 2019-11-11 |
| Report Date | 2019-12-21 |
| Date Reported to FDA | 2019-12-21 |
| Date Reported to Mfgr | 2020-01-10 |
| Date Added to Maude | 2020-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILSHIE CLIPS |
| Generic Name | DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE |
| Product Code | KNH |
| Date Received | 2020-01-10 |
| Model Number | TWENTY PAIR STERILE FILSHIE CLIPS |
| Catalog Number | AVM-851 |
| Lot Number | 37920 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FEMCARE LIMITED |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE, UT 84047 US 84047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |