MAUDE Adverse Event Report: FEMCARE LTD. FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Menstrual Irregularities (1959); Pain (1994)

Event Date 09/13/2018

Event Type  Injury  

Event Description

My doctor (without my permission) placed filshie clips on my fallopian tubes for a tubal ligation.I have had constant pain since then.My cycles are horrible.I feel these clips every time i go running.I have been treated like a pill pusher (even though i decline anything other than tylenol and anti-inflammatories) or a mental patient because i complain about the pain.These clips are known to break and migrate, they are known to embed themselves in other organs.They must be recalled.There needs to be revised consent forms in hospitals.Studies need to be redone.Fda safety report id #: (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 10349864
• MDR Text Key: 201401940
• Report Number: MW5095824
• Device Sequence Number: 2
• 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: 07/29/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Weight: 75