FDA Adverse Event
Injury
Summary report: N
FILSHIE CLIP
MDR report key: 2067218
·
Received April 15, 2011
Report
- Report Number
- 8021955-2011-00001
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- March 4, 2011
- Report Date
- April 12, 2011
- Manufacturer
- FEMCARE-NIKOMED LTD.
- Product Code
- KNH
- PMA / PMN Number
- P920046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE FILSHIE CLIP WAS NOT RETURNED TO U.S. DISTRIBUTOR (COOPER SURGICAL INC) OR MFR (FEMCARE-NIKOMED LTD) FOR EVAL. THIS EVENT ALSO REPORTED BY FEMCARE-NIKOMED U.S. DISTRIBUTOR COOPER SURGICAL INC - REPORT # 1216677-2011-0004. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2006, THE DOCTOR PERFORMED A FEMALE STERILIZATION FILSHIE CLIP TUBAL LIGATION PROCEDURE WITH NO PROBLEMS REPORTED. ON (B)(6) 2010, THE PT CALLED THE DOCTOR AND EXPLAINED THAT FOR 15 MONTHS SHE HAD BEEN SUFFERING PELVIC PAIN. THE DOCTOR SENT THE PT FOR A CT SCAN WHICH REVEALED THAT A FILSHIE CLIP WAS LOOSE (FLOATING) WITHIN THE PT'S ABDOMEN. NO SPECIFIC LOCATION REPORTED. ON (B)(6) 2011, THE DOCTOR PERFORMED A LAPAROSCOPIC PROCEDURE TO REMOVE THE LOOSE FILSHIE CLIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FILSHIE CLIP | FILSHIE CLIP | KNH | FEMCARE-NIKOMED LTD. | FE-20U-904 | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |