MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hair Loss (1877); Pain (1994); Weight Changes (2607); Heavier Menses (2666)

Event Date 09/06/2016

Event Type  Injury  

Event Description

(b)(4).Ever since i had my c section i experienced a different kind of pain that did not go away.I have had hair loss, weight gain, back pain, heavy periods.I am miserable.Having them removed (b)(6) 2017 which pisses me off because now i have to pay for it too.I would have never had the procedure if i had known the clips would be used or the side effects!.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6352834
• MDR Text Key: 68130979
• Report Number: MW5068065
• 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 Outcome(s): Required Intervention
• Patient Age: 32.000 YR