MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIP

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Heavier Menses (2666); Pregnancy (3193)

Event Type  Injury  

Event Description

I had filshie clips put on my fallopian tubes for sterilization.About 8 months later, i found out i was pregnant! after having my daughter, i asked for an x-ray to see where these clips went.My dr told me that the clips would not be visible on an x-ray.My periods became heavier so i had a hysterectomy.I've had pain off and on in the right pelvic area for years.When they did the hysterectomy, they said the left clip was next to my tube and the right one was not seen! i asked for an x-ray again after i recovered from surgery.They could see it very clearly on my right side (pelvic area).

• Brand Name: FILSHIE CLIP
• Type of Device: FILSHIE CLIP
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6293000
• MDR Text Key: 66345735
• Report Number: MW5067577
• 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: 01/30/2017

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CLONAZEPAM; MAXALT PRN; OTC MEDS: NONE; RX MEDS: ZOLOFT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 66