MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-08 for FILSHIE TUBAL LIGATION SYSTEM AVM-851 manufactured by Cooper Surgical.
[16449206]
During tubal ligation, filshie clip was put on the right fallopian tube. The clip did not completely approximate perfectly with the other side and actually went to the side and lacerated the fallopian tube. Diagnosis or reason for use: undesired fertility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040189 |
| MDR Report Key | 4417337 |
| Date Received | 2015-01-08 |
| Date of Report | 2015-01-08 |
| Date of Event | 2014-12-26 |
| Date Added to Maude | 2015-01-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILSHIE TUBAL LIGATION SYSTEM |
| Generic Name | FILSHITE CLIP |
| Product Code | HGB |
| Date Received | 2015-01-08 |
| Returned To Mfg | 2015-01-08 |
| Model Number | AVM-851 |
| Lot Number | 34093 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-08 |