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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PELVIC MESH MESH, SURGICAL, POLYMERIC

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PELVIC MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Material Disintegration (1177); Material Protrusion/Extrusion (2979)
Patient Problems Unspecified Infection (1930); Pain (1994); Weakness (2145); Immunodeficiency (2156); Disability (2371)
Event Date 01/01/1998
Event Type  No Answer Provided  
Event Description
Pt called to report adverse events involving her pelvic mesh she had implanted in 1998. Pt stated she had a hysterectomy in 1998 and had the mesh implanted and has experienced problems ever since. Pt stated she went on disability, had shingles 20 times, and was hospitalized over 30 times with infections. Pt experienced symptoms such as painful intercourse, bad odor coming from vaginal area, ruined her immune system, no energy, infections, feeling like she was being poisoned. Pt said she had mesh removal surgery on (b)(6) 2019 and feels much better now. Pt said she was told by physician that the mesh was disintegrating in her body and was hanging out of her vagina. Pt stated people thought she was crazy, but she was sick from the mesh. Pt also reported the original implanting surgeon left a surgical towel in her that had been rotting. Pt stated she has the same mesh implanted in her head from a brain surgery and is worried that mesh will also disintegrate into her brain.
 
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Brand NamePELVIC MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
MDR Report Key8456935
MDR Text Key140330925
Report NumberMW5085221
Device Sequence Number1
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 03/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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

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