MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Abdominal Pain (1685); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Dizziness (2194); Pregnancy (3193)
Date of Event	02/01/2007
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Severe pain in my pelvic, rectum, and abdomen area.Severe dizziness and nausea.I had gotten pregnant once in my tubes.Painful periods and many hospital visits.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 7215454
• Report Number: MW5074827
• Device Sequence Number: 17590631
• Product Code: KNH
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/26/2017

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
• Operator of Device: No Information
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 39.000 YR