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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX SURGICAL MESH Back to Search Results
Model Number 0115320
Device Problems Defective Device (2588); Folded (2630)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 11/13/2013
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. Based on the information provided, it is alleged the patient experienced hernia recurrence, pain and adhesions. Recurrence and adhesions are known inherent risks of hernia surgery and are identified in the adverse reaction section of the instructions-for-use as possible complications. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. This file represents the 3dmax mesh device (device #1) implanted on the patient's right side, a second emdr was submitted to address the 3dmax mesh device (device #2) implanted on the patients left side. Not returned to manufacturer.

 
Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2012 - the patient underwent surgery for repair of bilateral inguinal hernias, two bard 3dmax mesh devices (device #1 & device #2) were implanted to repair the hernia defects. (b)(6) 2013 - the patient underwent an additional surgery to repair a hernia defect on the right side and remove some old folded mesh. (b)(6) 2014 - the patient underwent an additional surgery to repair a hernia defect on the left side and remove a piece of the old mesh. (b)(6) 2015 - the patient underwent an additional surgery to once again repair the hernia defect on the right side, however, the procedure was aborted due to dense adhesions and the inability to separate he mesh from the perineum. The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.

 
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Brand Name3DMAX
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 Key7130894
MDR Text Key95325861
Report Number1213643-2017-01071
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 12/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2017
Device MODEL Number0115320
Device Catalogue Number0115320
Device LOT NumberHUWB1374
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 Received11/29/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/07/2012
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: 12/19/2017 Patient Sequence Number: 1
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