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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL, INC. SUB. C.R. BARD. INC. 3DMAX LIGHT MESH; MESH, SURGICAL, POLYMERIC
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DAVOL, INC. SUB. C.R. BARD. INC. 3DMAX LIGHT MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 0117311
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Rash (2033); Burning Sensation (2146); Numbness (2415)
Event Date 05/01/2017
Event Type  Injury  
Event Description
Patient called to report adverse event involving his 3dmax mesh, which was implanted on (b)(6) 2017 for a left inguinal hernia.Patient stated that since implantation of the mesh, he's had constant pain and feels worse than before the surgery.Patient said he has constant abdominal pain, left side burning, stinging and numbness, issues with his tongue and mouth, rash, cant sit or stand too long, and his left leg goes numb.Patient stated he can no longer work and is on disability.Patient stated he had a second surgery on (b)(6) 2018 to help relieve pain, but he's still having issues and constant chronic pain.Patient said he is trying to find out more information about his mesh, but his doctors will no longer help him.
 
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Brand Name
3DMAX LIGHT MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
DAVOL, INC. SUB. C.R. BARD. INC.
MDR Report Key8717456
MDR Text Key148809789
Report NumberMW5087493
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 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number0117311
Device Catalogue Number0117311
Device Lot NumberHUBN1556
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age46 YR
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