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

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Nausea (1970); Pain (1994); Dizziness (2194); Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2019

Event Type  Injury  

Event Description

I got tubal ligation in (b)(6) 2008.I was under impression that they would be cut and cauterized but were actually but were actually clamped with clips.I wasn't informed of this until after surgery.I have been having severe pain, dizziness and nausea for months.I went to the hosp on (b)(6)2019 and they ordered a ct scan.The scan revealed that the left clip on my left fallopian tube had come off and is free floating in my pelvis area.Since this is so recent, the clip is still in my body and i will need surgery to remove it.I'm still having severe pain in my lower left pelvis area.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPER SURGICAL, INC.
• MDR Report Key: 8822343
• MDR Text Key: 152205132
• Report Number: MW5088331
• 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: 07/21/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 40 YR
• Patient Weight: 64