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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 3D MAX MESH SURGICAL MESH Back to Search Results
Catalog Number 0115311
Device Problems Defective Device; Insufficient Information
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event. The patient's attorney did not allege a specific device failure and medical records have not been provided. Without a lot number a review of the manufacturing records could not be conducted. With the currently available information, no conclusion can be drawn. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. 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. Not returned to manufacturer.

 
Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2016--patient underwent a left direct inguinal hernia repair with implant of a large left 10. 8 cm x 16 cm bard davol 3d max mesh and a non bard/davol ethicon prolene mesh. It is alleged post implant the patient's condition worsened due to complications of one or both mesh products. It is alleged the patient has lost feeling in most of his left leg and is dealing with pain in the surrounding areas. Patient has limited mobility, and cannot perform basic tasks that he used to. Patient has suffered seizures and erectile dysfunction. The attorney alleges the patient experienced pain and suffering, nerve damage, limited mobility, additional non-invasive medical treatment and disability.

 
Manufacturer Narrative

Addendum to the initial report. This supplemental report is being sent to provide the lot number for the 3d max mesh device as well as other medical history. The date of implantation for the mesh device was also updated. A manufacturing review was performed and found no evidence of a manufacturing related cause for the reported event. With the current information available no conclusion can be made. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. Not returned to manufacturer.

 
Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2014 - patient underwent a left direct inguinal hernia repair with implant of a large left 10. 8 cm x 16 cm bard davol 3d max mesh and a non bard/davol ethicon prolene mesh. It is alleged post implant the patient's condition worsened due to complications of one or both mesh products. It is alleged the patient has lost feeling in most of his left leg and is dealing with pain in the surrounding areas. Patient has limited mobility, and cannot perform basic tasks that he used to. Patient has suffered seizures and erectile dysfunction. The attorney alleges the patient experienced pain and suffering, nerve damage, limited mobility, additional non-invasive medical treatment and disability. Addendum: based on the additional information received, it is alleged the patient could not undergo additional medical treatment including surgery due to it being "fatal because of the mesh being around vital organs. " it is further alleged the patient "cannot have certain types of tests and cannot have surgery. ".

 
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Brand Name3D MAX MESH
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
steven figueroa
100 crossings blvd.
warwick , RI 02886
4018258460
MDR Report Key5679872
Report Number1213643-2016-00235
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 05/26/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2018
Device Catalogue Number0115311
Device LOT NumberHUXJ1022
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/26/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/24/2013
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: 05/25/2016 Patient Sequence Number: 1
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