MAUDE Adverse Event Report: COOPER SURGICAL / FEMCARE LTD. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Laceration(s) (1946); Pain (1994); Unspecified Nervous System Problem (4426)

Event Date 10/01/2006

Event Type  Injury  

Event Description

In 2006 i had a bilateral tubal ligation where filshie clips were used.In 2015 i began to experience neurological issues in my extremities.These issues were addressed both with primary care and chiropractic doctors.Pain medications, muscle relaxers were prescribed.In 2022 nerve pain became acute with pain levels at 7-8 out of 10 most days.Xrays revealed the clips had migrated to the lower right pelvic area.Laparoscopic surgery was performed on (b)(6) 2022.A clip was located in the fold of peritoneum overlying the bladder.The peritoneum had to be incised for the clip to be removed.The second clip was located in the retroperitoneal space just medial to the right round ligament.The round ligament was cauterized and cut.The retroperitoneal opening was extended bluntly.Gentle blunt dissection was performed along the iliac vessels until the clip was located and grasped and dissected out from the surrounding tissue.Six weeks after surgery there has been no pain at all; no pelvic pain; no neurological pain.It is blatantly obvious the cause of the extreme pain felt over the past seven years.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL / FEMCARE LTD.
• MDR Report Key: 15321225
• MDR Text Key: 298982851
• Report Number: MW5111781
• 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: 08/26/2022

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: 08/29/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 37 YR
• Patient Sex: Female