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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD MARLEX MESH

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C. R. BARD MARLEX MESH Back to Search Results
Device Problems Therapeutic or Diagnostic Output Failure (3023); Unintended Movement (3026)
Patient Problems Abdominal Pain (1685); Tissue Damage (2104)
Event Date 04/11/2015
Event Type  Injury  
Event Description
In (b)(6) of 2010 had a inguinal hernia repaired using marlex mesh. In (b)(6) of 2015 was experiencing abdominal pain and after seeking the device of a surgeon had to have the original repair repaired. Upon removal of original mesh doctor noted that the mesh was cutting him through his glove and that the edge of the mesh was not sealed as normal mesh would be. The mesh had entangled many internal organs and cut off the blood supply to left testicle. Left testicle had to be removed 8 days later due to lack of blood supply. After this i started doing research and found out that the fda had issued a recall for the same things months prior to my original surgery. Was this mesh missed on the original recall or was it a new lot of mesh that had not been previously reported?.
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Type of DeviceMARLEX MESH
Manufacturer (Section D)
MDR Report Key5603264
MDR Text Key43761900
Report NumberMW5061846
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 04/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2016
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/20/2016 Patient Sequence Number: 1