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

Lot Number 36083

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Hormonal Imbalance (4495)

Event Date 06/08/2021

Event Type  Injury  

Event Description

In 2016 had tubal ligation via filshie clip.From 2019-2021 started experiencing severe abdominal, pelvic pain, hormone irregularities, and gastric problems.Problems intensified so much in (b)(6) 2021 i started seeing doctors.After no success with other treatments, i had exploratory surgery in (b)(6) 2021.Exploratory surgery showed intra-abdominal adhesions formed to anterior abdominal wall in the omentum.Additional adhesions involving left filshie clip, left fallopian tube and bowels.The right fallopian tube was transected partially already and right filshie clip migrated and was found in the omentum.The right filshie clip was excised and removed from omentum.I now have developed adhesion disease due to the internal damages the migrated device has caused my pelvic and abdominal area.I will now have to live with severe adhesions for the rest of my life the formation of these severe adhesions has continued to limit my life.This adverse event continues to affect my mobility, my bodies normal capabilities, and has caused my medical care to be an ongoing process.This has been a life altering side affect.Can send over documents.Fda safety report id # (b)(4).

• Brand Name: TELFA FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 12633830
• MDR Text Key: 276886793
• Report Number: MW5104617
• 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: 10/11/2021

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
• Device Lot Number: 36083
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 29 YR
• Patient Weight: 54