MAUDE Adverse Event Report: COOPER MEDICAL / COOPERSURGICAL, INC. FILSHIE CLIPS FOR FEMALE STERILIZATION; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Dysuria (2684)

Event Date 02/15/2021

Event Type  Injury  

Event Description

I had clips placed for sterilization in (b)(6) 2017.The metal filshie clips that were supposed to be on my tubes embedded in my bladder.Doctor found them during hysterectomy ((b)(6) 2021) procedure.Caused painful urination and severe abdominal pain for the last few months.If you need more info please contact me.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS FOR FEMALE STERILIZATION
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER MEDICAL / COOPERSURGICAL, INC.
• MDR Report Key: 11349501
• MDR Text Key: 232899911
• Report Number: MW5099507
• Device Sequence Number: 1
• Product Code: KNH
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 27 YR
• Patient Weight: 79