MAUDE Adverse Event Report: COOPER SURGICAL TRUMBULL CT FILSHIE CLIPS

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Rash (2033)

Event Date 01/13/2015

Event Type  Injury  

Event Description

In (b)(6) 2008 i received filshie clips without my knowledge.I have severe stabbing pain, i break out in hives daily, severe migraines, memory loss and fatigue.They have ruined my life and thousands of other women.Was not told and was not informed of side effects.

• Brand Name: FILSHIE CLIPS
• Type of Device: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL TRUMBULL CT
• MDR Report Key: 4438848
• MDR Text Key: 5384934
• Report Number: MW5040294
• Device Sequence Number: 1
• Product Code: HGB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Other Device ID Number: HOWARD BEAUMONT STUART CT, SPU
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 26 YR
• Patient Weight: 136