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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 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117311
Device Problem Insufficient Information
Event Date 02/20/2016
Event Type  Injury  
Manufacturer Narrative

The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

 
Event Description

The following was reported via maude event report (mw5068837): "bard 3dmax light mesh implanted for inguinal hernia. Constant pain for one year and two months following surgery. Problem was ignored in subsequent visits to surgeon; was told to take large doses of ibuprofen on a constant and ongoing basis. Missed 4 days of work in the last week; visited emergency room; cat scan showing nothing; diagnosis was adhesion due to the mesh implantation; was told to see surgeon who performed hernia surgery. Visited surgeon again, 2017; surgeon has refused to remove mesh-says he can do nothing. Referred to pain doctor for pain medication rather than addressing the problem with implanted mesh. Mesh is still implanted. I am in constant pain. Unknown if i will be able to continue working. I do not want to take opioids for pain; i want the mesh removed and problem resolved. Severe, constant abdominal pain from implant bard 3dmax light left large mesh implant. ".

 
Manufacturer Narrative

No lot number has been provided; therefore a review of the manufacturing records and related manufacturing process reviews could not be performed. Adhesions are a known inherent risk of surgery and are listed in the adverse reaction section of the ifu as a possible complication. Multiple attempts have been made to request additional information. At this time, no additional information has been provided. Based on the information available at this time, no conclusions can be made. Should additional information be provided, a supplemental mdr will be submitted. Note - the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Remains implanted.

 
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Brand Name3DMAX LIGHT
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
laura berg
100 crossings blvd.
warwick , RI 02886
4018258462
MDR Report Key6589314
Report Number1213643-2017-00328
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/02/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number0117311
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/24/2017 Patient Sequence Number: 1
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