MAUDE Adverse Event Report: FILSHIE CLIP; TUBAL OCCLUSION DEVICE

Device Problem Malposition of Device (2616)

Patient Problem Abdominal Pain (1685)

Event Date 09/19/2013

Event Type  Injury  

Event Description

Six week postpartum dr performed tubal utilizing filshie clip experienced gain.Severe abdominal pain after 2.5 years of complaint about pain exploratory surgery was performed and located the clips one floating the other lodged behind uterus.

• Brand Name: FILSHIE CLIP
• Type of Device: TUBAL OCCLUSION DEVICE
• MDR Report Key: 6102685
• MDR Text Key: 59988829
• Report Number: MW5066032
• 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: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 29 YR
• Patient Weight: 61