MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

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

Patient Problems Pain (1994); Scar Tissue (2060); Heavier Menses (2666)

Event Date 02/23/2017

Event Type  Injury  

Event Description

(b)(4).I got them on in (b)(6) 2012.I started have sharp pain in my lower sides; i went back a forth to doctor; they put me in the (b)(6); that didn't help; my period was vary heavy; i would bleed for 3 weeks at a time; i would go through about 30 tampons a day so in (b)(6) of 2016 the doctor did a scar tissue removal.Still the pain was there.Nothing seemed to help.In (b)(6) of 2016 the doctor did a hysterectomy.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6352832
• MDR Text Key: 68130691
• Report Number: MW5068064
• 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
• Treatment: THE ONLY THING I WAS USING WAS THE FILSHIE CLIPS.
• Patient Outcome(s): Other
• Patient Age: 28.000 YR