FDA Adverse Event
Injury
Summary report: N
FILSHIE CLIPS
MDR report key: 2067848
·
Received April 14, 2011
Report
- Report Number
- 1216677-2011-00004
- Event Type
- Injury
- Date Received
- April 14, 2011
- Date of Event
- March 4, 2011
- Report Date
- April 12, 2011
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- KNH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FILSHIE CLIP HAS NOT BEEN RETURNED TO COOPERSURGICAL INC. FOR EVAL. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2006, THE DOCTOR PERFORMED THE PROCEDURE WITH NO PROBLEMS. ON (B)(6) 2010, THE PT CALLED THE DOCTOR AND EXPLAINED THAT FOR 15 MONTHS SHE HAD PELVIC PAIN. THE DOCTOR SENT HER FOR A CT SCAN AND ONE OF THE CLIPS WAS FLOATING. ON (B)(6) 2011, THE DOCTOR DID A LAPAROSCOPY (REMOVAL OF THE FILSHIE CLIP).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FILSHIE CLIPS | NONE | KNH | COOPERSURGICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |