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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL, INC. SUB. C. R. BARD, INC. 3DMAX MESH MESH, SURGICAL, POLYMERIC

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DAVOL, INC. SUB. C. R. BARD, INC. 3DMAX MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Swelling (2091)
Event Date 03/30/2016
Event Type  Injury  
Event Description
Pt called to report an adverse event involving his 3dmax mesh he had implanted on (b)(6) 2016. Pt stated 6 weeks after surgery, his swelling became worse. Pt stated he was in severe pain, had complications with bowel movements, and citrus foods and tomato cause upset him. Pt said he went to the emergency room (er) 3 times, the last time was the friday after (b)(6) in 2018, where he was referred to a surgeon. Pt said he saw the surgeon the following week and was told the mesh needed to be removed. Pt had the mesh removed on (b)(6) 2018 and had a different mesh put in. Pt stated his complication was identified as "meshoma", where the mesh came loose from the sutures and became rolled up inside him.
 
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Brand Name3DMAX MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
DAVOL, INC. SUB. C. R. BARD, INC.
MDR Report Key8843459
MDR Text Key153060138
Report NumberMW5088548
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 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
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
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: 07/29/2019 Patient Sequence Number: 1
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