MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-09 for FILSHIE CLIPS manufactured by .
[3727067]
The pt on (b)(6) 2013, had a procedure at the hospital for "laparoscopic left salpingectomy removal of bilateral fallopian clips, and laparoscopic lyses of adhesions. " the pt had bilateral fallopian tube clip application with filshie clips in the year 2009 at unknown facility. She began having more pain recently and a ct scan showed the right fallopian tube clip was located in the lower pelvis on the left side of the pt. The findings revealed the pt had adhesions of the left fallopian tube and left fallopian tube clip to the left fallopian tube and left fallopian tube clip to the left pelvic sidewall. The right fallopian tube clip free-floating lying on the bladder flap near the left tube not with any attachments to the pt. Right fallopian tube was with evidence of separation. No evidence of endometriosis in the pelvis. No other information was found related to the clips and when or where they were originally placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3347375 |
| MDR Report Key | 3347375 |
| Date Received | 2013-09-09 |
| Date of Report | 2013-09-08 |
| Date of Event | 2013-08-22 |
| Date Facility Aware | 2013-08-22 |
| Report Date | 2013-09-08 |
| Date Reported to FDA | 2013-09-09 |
| Date Added to Maude | 2013-09-16 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILSHIE CLIPS |
| Generic Name | FILSHIE CLIPS |
| Product Code | HGB |
| Date Received | 2013-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2013-09-09 |