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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS
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COOPER SURGICAL FILSHIE CLIPS Back to Search Results
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fatigue (1849); Headache (1880); Menstrual Irregularities (1959); Pain (1994); Irregular Pulse (2469); Heavier Menses (2666)
Date of Event 05/21/2014
Type of Reportable Event Serious Injury
Event or Problem Description
(b)(4).Suffering from pelvic pain, irregular periods, headaches, thigh pain, heavy periods with clotting difficulties with bowel and bladder, irregular heart rate, fatigue.Since ligation.Asked for cut and tie just found out after 5 years that i had clips placed.
 
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Brand Name
FILSHIE CLIPS
Manufacturer (Section D)
COOPER SURGICAL
MDR Report Key7215342
Report NumberMW5074820
Device Sequence Number115662
Product Code KNH
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 12/20/2017
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 Date01/24/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age36.000 YR
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