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); Ectopic Pregnancy (1819); Nausea (1970); Pain (1994); Dizziness (2194); Depression (2361)
Date of Event	02/26/2002
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).I have experienced depression with these clamps and severe pain on the right side of my abdomen.The pain is so severe i can't stand up and have lay in a fetal position.I have severe rectum and pelvic pain, dizziness, nausea, and i have experienced an ectopic pregnancy.I have suffered emotionally through.The years because explaining this to the emergency room (er) or my doctor no one understood and i had an laparoscopy surgery for nothing to try and fix the problem, but experienced the same severe pain 1 hour after surgery.I tried telling my doctor that i knew it was the clamps and other doctors to but i got ignored and set home with 800 mg ibuprofen.Please help.This pain comes on sudden and catches you off guard and this was not happening before i got these clamps.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 7215470
• Report Number: MW5074834
• Device Sequence Number: 178851
• 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; Other
• Patient Age: 39.000 YR