MAUDE Adverse Event Report: FILSHIE CLIPS

FILSHIE CLIPS

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
Tubal ligation clamps, i was not given the dangerous or warnings.I have since suffered with abdominal pain, sharp pain, heavy bleeding, and i have not felt like myself since the procedure.

Search Alerts/Recalls

1 Device was Involved in the Event
Brand Name	FILSHIE CLIPS
Common Device Name	FILSHIE CLIPS
MDR Report Key	7251079
Report Number	MW5075130
Device Sequence Number	1063752
Product Code	KNH
Combination Product (Y/N)	N
Initial Reporter State	MI
Initial Reporter Country	US
Number of Events Summarized	1
Summary Report (Y/N)	N
Reporter Type	Voluntary
Initial Reporter Occupation	Patient
Type of Report	Initial
Report Date (Section B)	02/06/2018
1 Patient was Involved in the Event
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Operator of Device	Health Professional
Was Device Available for Evaluation?	Yes
Initial Date Received by Manufacturer	Not provided
Initial Report FDA Received Date	02/07/2018
Patient Sequence Number	1
Outcome Attributed to Adverse Event	Disability;
Patient Age	35 YR
Patient Weight	64