MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Headache (1880); Menstrual Irregularities (1959); Pain (1994); Weight Changes (2607)

Event Date 02/11/2011

Event Type  Injury  

Event Description

(b)(4).My period was a week late in (b)(6) 2011.I went to my dr out of concern.I wasn't pregnant.After that my lower stomach would feel sore off and on.In (b)(6) when i got my period the pain was so bad i had to take a pain pill and use a heating pad.This helped dull the pain enough for me to be able to move eventually.After that i would have bad pains like that during my period, my stomach would feel sore off and on.Back pain, weight gain (no matter what i tried to lose) irregular periods and i would have more migraines then usual.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6405997
• MDR Text Key: 69986869
• Report Number: MW5068452
• 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: 03/14/2017

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: 03/15/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 30.000 YR