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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MESH MESH, SURGICAL, POLYMERIC

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MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Urinary Tract Infection (2120)
Event Date 06/07/2016
Event Type  Injury  
Event Description
Chronic infections and pain; had a gynecological surgery in (b)(6) 2014 with mesh placement. I've had chronic uti, pain, and urinary related issues. It has caused so many problems and i was unaware that the product that was supposed to improve life would cause life changing issues. Fda safety report id# (b)(4).
 
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Brand NameMESH
Type of DeviceMESH, SURGICAL, POLYMERIC
MDR Report Key12008130
MDR Text Key256772573
Report NumberMW5101918
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/15/2021 Patient Sequence Number: 1
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