FILSHIE CLIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for FILSHIE CLIPS manufactured by Cooper Surgical / Femcare Ltd..

Event Text Entries

[175699971] In 2011 i had filshie clips put in (b)(6). The dr placed 4 filshie on both my fallopian tubes, two on each side. Two years later, i started experiencing pain and heavy bleeding. Years of pain and misdiagnoses; later we discovered that they had migrated. I had 3 of the filshie clips removed in (b)(6) on (b)(6) 2020. I now have to have a ct scan to find the missing 4th filshie clip. This has caused me to loose jobs and relationships. My children have been watching their mother suffer. These clips need to be pulled from the market. There are millions of women experiencing the same issues. These are toxic and defected. Please protect united states citizens by not allowing these to be used any further. This has been a nightmare. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092300
• MDR Report Key: 9596273
• Date Received: 2020-01-15
• Date of Report: 2020-01-14
• Date of Event: 2020-01-08
• Date Added to Maude: 2020-01-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: FILSHIE CLIPS
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Product Code: KNH
• Date Received: 2020-01-15
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL / FEMCARE LTD.

Device Sequence Number: 2

• Brand Name: FILSHIE CLIPS
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Product Code: KNH
• Date Received: 2020-01-15
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL / FEMCARE LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-01-15