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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERVICAL MESH MESH SURGICAL, SYNTHETIC UROGYNECOLOGIC

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CERVICAL MESH MESH SURGICAL, SYNTHETIC UROGYNECOLOGIC Back to Search Results
Device Problems Migration or Expulsion of Device (1395); Nonstandard Device (1420)
Patient Problems Unspecified Infection (1930); Discomfort (2330)
Event Date 06/07/2017
Event Type  Injury  
Event Description

In 2009, i had a cervical stitch implanted so that i could have a successful pregnancy. After delivery, the doctor did not remove the mesh stitch and i began to have complication a few years later. The symptoms became worst and i changed doctors to get better answers. After several test, the results showed that the cervical stitch had shifted and become embedded in my cervical wall causing infection, tearing, discomfort, bad odor and had become harden. The doctor removed the cervical stitch and had to perform a d and c. I am asking that you help me to find out if there is any recall info on cervical stitch.

 
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Brand NameCERVICAL MESH
Type of DeviceMESH SURGICAL, SYNTHETIC UROGYNECOLOGIC
MDR Report Key6809686
MDR Text Key83454343
Report NumberMW5071732
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 08/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? 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

Patient TREATMENT DATA
Date Received: 08/22/2017 Patient Sequence Number: 1
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