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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Hair Loss (1877); Hormonal Imbalance (4495)

Event Date 12/20/2018

Event Type  Injury  

Event Description

Got tubal ligation with filshie clips.Suffer from hair loss , chronic abdominal pain, hormonal issues etc.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: 13025712
• MDR Text Key: 282584134
• Report Number: MW5106126
• 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: 12/14/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White