MAUDE Adverse Event Report: FEMCARE, LTD. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSIVE DEVICE

Device Problems Break (1069); Migration (4003); Sharp Edges (4013)

Patient Problems Pain (1994); Malaise (2359); Abdominal Distention (2601)

Event Date 06/16/1999

Event Type  Injury  

Event Description

Tubal used filshie clips without my consent or knowledge causing years of no periods, severe pain, bloating and sickness.Several years of dr appts and problems.Believe they're sharp, broken and migrated.Bladder pain and problems.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSIVE DEVICE
• Manufacturer (Section D): FEMCARE, LTD.
• MDR Report Key: 8949888
• MDR Text Key: 156318939
• Report Number: MW5089473
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 75