MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Hair Loss (1877); Cramp(s) (2193); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Date 03/15/2010

Event Type  Injury  

Event Description

(b)(4).I have had many side effects since having the clips put in.Extra heavy periods, intense cramps, random stabbing abdominal pains, bloating, hair loss, trouble losing weight.I did not have any of these issues before the filshie clips.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6352860
• MDR Text Key: 68132833
• Report Number: MW5068069
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/23/2017

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: 02/23/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36.000 YR