MAUDE Adverse Event Report: FILSHIE CLIP; NONE

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 02/20/2011

Event Type  Injury  

Event Description

I received this clips when i asked for a tubal back in 2011.I have had nothing but problems and pain ever since.I changed physicians since then because the physician who put them on did so, even when i specifically asked for them to, but cut and tied.My physician i have now, has never heard of these and had to resource to find out about them.They came back with horrible news.She said they were not good.The main problem is they are falling off and becoming dislodged elsewhere.I have been suffering in pain for the last 3 years and have had test after test looking for what the problem is and this is the only thing left.This product should be recalled and investigate before it becomes a huge problem.

• Brand Name: FILSHIE CLIP
• Type of Device: NONE
• MDR Report Key: 4375294
• MDR Text Key: 5236466
• Report Number: MW5039830
• Device Sequence Number: 0
• 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: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 104