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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. PERFIX PLUG MESH MESH SURGICAL POLYMERIC

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C. R. BARD, INC. PERFIX PLUG MESH MESH SURGICAL POLYMERIC Back to Search Results
Model Number DNT 13999441/MODL
Device Problem Insufficient Information (3190)
Patient Problems Muscle Spasm(s) (1966); Pain (1994); Numbness (2415); Ambulation Difficulties (2544)
Event Date 01/30/2018
Event Type  Injury  
Event Description
Reporter alleges she experienced severe muscle spasm in her legs a day after being implanted with perfix plug mesh for hernia repair. Reporter advised she was pain free when in bed. However, activities of daily living became hard to accomplish as sitting, standing, walking and general ambulation came with excruciating pain. Lastly, she alleges numbness of lower extremities and continues to experience it even after device explant.
 
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Brand NamePERFIX PLUG MESH
Type of DeviceMESH SURGICAL POLYMERIC
Manufacturer (Section D)
C. R. BARD, INC.
MDR Report Key7681120
MDR Text Key113797801
Report NumberMW5078318
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 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDNT 13999441/MODL
Device Catalogue Number1177920
Device Lot NumberHUBS 0615
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: 07/11/2018 Patient Sequence Number: 1
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