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

Device Problem Migration (4003)

Patient Problems Abdominal Pain (1685); Menstrual Irregularities (1959); Scar Tissue (2060); Dyspareunia (4505)

Event Date 07/27/2020

Event Type  Injury  

Event Description

I had to have surgery; i had clips put on my tubes in 2018 while getting my tubes tied without giving the doctor permission.I experienced painful sexual intercourse abdonimal pain and painful menstrual cycles for years.After having a transvaginal ultrasound, they found i had an indentation in my uterus.It went inward like something was stuck in there i had to get laparoscopic surgery the clips were found and had migrated and a bunch of scar tissue was removed.I now can live a normal life again but i would not recommend these tubes to anyone and doctors should not be allowed to use them without permission.Fda safety report id# (b)(4).

• Brand Name: TUBAL CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 10816102
• MDR Text Key: 216007107
• Report Number: MW5097738
• Device Sequence Number: 1
• Product Code: KNH
• 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: 11/05/2020

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 68