MAUDE Adverse Event Report: FILSHIE CLIPS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Pain (1994)

Event Type  Injury  

Event Description

Tubal ligation clamps, i was not given the dangerous or warnings.I have since suffered with abdominal pain, sharp pain, heavy bleeding, and i have not felt like myself since the procedure.

• Brand Name: FILSHIE CLIPS
• Type of Device: FILSHIE CLIPS
• MDR Report Key: 7251079
• MDR Text Key: 99578078
• Report Number: MW5075130
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 35 YR
• Patient Weight: 64