MAUDE Adverse Event Report: FEMCARE-NIKOMED FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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

Patient Problems Hair Loss (1877); Pain (1994); Myalgia (2238); Numbness (2415); No Code Available (3191)

Event Date 04/20/2017

Event Type  Injury  

Event Description

I had filshie clips placed on my fallopian tubes (b)(6) 2017.Within a week of surgery i began having sharp pain, muscle weakness, limbs going numb, severe hormonal changes and hair falling out.The problems only got worse.The dr who placed my clips did not inform me of these side effects.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE-NIKOMED
• MDR Report Key: 8231451
• MDR Text Key: 132854786
• Report Number: MW5082975
• Device Sequence Number: 0
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 30 YR
• Patient Weight: 77