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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC

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COVIDIEN POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682); Expulsion (2933)
Patient Problems Anaphylactic Shock (1703); Autoimmune Disorder (1732); Failure of Implant (1924); Incontinence (1928); Pain (1994); Urticaria (2278); Sensitivity of Teeth (2427); Tissue Breakdown (2681)
Event Date 07/01/2006
Event Type  Injury  
Event Description
I got very sick, acute urticaria, anaphylactic, hosp; not until (b)(6) 2012, did the (b)(6) clinic discover mesh erosion through my bladder, vagina, colon and rectum. Tried to have it surgically removed to no avail. Sick every day of my life, loss total bladder function, autoimmune disease, constant infections, now losing my teeth. (b)(6) clinic has told me that the mesh will erode through my colon and i will have a colostomy bag for life. Currently on full disability, have to self catheter, constant pain and cannot have sexual relationships with my husband. Bladder function has 0% function. Tvm mesh eroding through bladder, vagina, colon and rectum. Fda safety report id#: (b)(4).
 
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Brand NamePOLYPROPYLENE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
COVIDIEN
MDR Report Key9193072
MDR Text Key162537233
Report NumberMW5090387
Device Sequence Number2
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/10/2019
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received10/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 10/11/2019 Patient Sequence Number: 1
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