MAUDE Adverse Event Report: FLISHIE CLIP

Device Problems Entrapment of Device (1212); Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Headache (1880); Anxiety (2328); Abdominal Cramps (2543); Heavier Menses (2666)

Event Date 05/05/2009

Event Type  Injury  

Event Description

In 2009 i had filshie clips placed after undergoing a c-section.Since the clips have been in place i have had massive migraines, anxiety attacks, severe abdominal cramping, very heavy periods, major mood swings, and a ton more adverse effects from these clips.In 2012 it was found that the clips had imbedded into my uterus, causing the major pain i experience.

• Brand Name: FLISHIE CLIP
• Type of Device: FLISHIE CLIP
• MDR Report Key: 3664677
• MDR Text Key: 18729841
• Report Number: MW5034804
• 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: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 95