MAUDE Adverse Event Report: FEMCARE - NIKOMED LTD FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL

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

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/04/2018

Event Type  Injury  

Event Description

I had the clips placed on my tubes as a form of sterilization; 4 months later i've had nothing but severe pain.The pain is in my back, my pelvic area, the pain goes down to my leg.I can barely walk.

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL
• Manufacturer (Section D): FEMCARE - NIKOMED LTD
• MDR Report Key: 8074941
• MDR Text Key: 127372030
• Report Number: MW5081327
• 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: 11/09/2018

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 27 YR
• Patient Weight: 108