MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Expulsion (2933)

Patient Problems Menstrual Irregularities (1959); Pain (1994); Inadequate Pain Relief (2388); Heavier Menses (2666)

Event Date 05/12/2012

Event Type  Injury  

Event Description

A reporter called to report that one year after she had her laparoscopic tubal ligation with the use of filshie clips she would have server pain and takes 800mg ibuprofen.She reports that her pain relief is inadequate and that it "just takes the edge off".She reports that she once felt extreme pressure in her abdomen when she went to urinate and she felt a piece of clip drop and land in the bottom of the toilet.Reporter states that her menstrual cycle is very painful; she has heavy bleeding with clots.

• Brand Name: FILSHIE CLIPS
• Type of Device: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6080962
• MDR Text Key: 59396189
• Report Number: MW5065827
• 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: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13 YR
• Patient Weight: 68