FDA Adverse Event
Injury
Summary report: N
FILSHIE CLIP
MDR report key: 7762555
·
Received August 7, 2018
Report
- Report Number
- MW5078939
- Event Type
- Injury
- Date Received
- August 7, 2018
- Date of Event
- May 30, 2018
- Report Date
- August 3, 2018
- Manufacturer
- UNK
- Product Code
- KNH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AR, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I EXPERIENCED ABDOMINAL PAIN, PAIN DURING INTERCOURSE, HEAVY MENSTRUAL PERIODS, AND HEADACHES/MIGRAINES FOR 6 YEARS WITH DIFFERENT DRS TELLING ME DIFFERENT THINGS. I HAD LAPAROSCOPIC SURGERY IN (B)(6) 2018 TO HAVE THE FILSHIE CLIPS REMOVED BECAUSE I STRONGLY FELT THAT WAS THE PROBLEM AND SINCE THEN ALL OF MY ISSUES HAVE STOPPED. I HAVE BEEN ON MEDICATION FOR MIGRAINES SINCE 2012 AND NOW I NO LONGER TAKE IT. I WAS NEVER TOLD OF ANY SIDE EFFECTS OR SYMPTOMS OF THE FILSHIE CLIPS BEFORE HAVING THEM PUT IN. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2012; DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2018. REASON FOR USE: TUBAL LIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600051 | FILSHIE CLIP | LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE | KNH | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |