MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

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

Patient Problems Cyst(s) (1800); Headache (1880); Pain (1994); Heavier Menses (2666)

Event Date 11/06/2010

Event Type  Injury  

Event Description

(b)(4).Since (b)(6) 2010 i have been in so much pain from a sharp knife feeling in my legs, heavy menstrual cycle, migraine,cyst on both ovaries, pain in anal, and pain during intercourse.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6356838
• MDR Text Key: 68268623
• Report Number: MW5068109
• 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: 02/24/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 31.000 YR