MAUDE Adverse Event Report: COOPERSURGICAL, INC. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Migration (4003)

Patient Problems Fatigue (1849); Incontinence (1928); Pain (1994); Hematuria (2558); Abdominal Distention (2601); Heavier Menses (2666)

Event Type  Injury  

Event Description

Left tube filshie tubal ligation clip migrated to above left ilium, chronic pelvic pain, autoimmune like issues, chronic fatigue, very bad pms, heavy periods followed by no period for months; bloating, ibs symptoms, stabbing and shocking pain in lower back, urinary incontinence, blood in urine.

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 8296954
• MDR Text Key: 135429681
• Report Number: MW5083615
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/30/2019

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 28 YR
• Patient Weight: 72