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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED SURGICAL MESH Back to Search Results
Catalog Number 0112710
Device Problems Defective Device (2588); Torn Material (3024); Material Split, Cut or Torn (4008)
Patient Problems Adhesion(s) (1695); Nerve Damage (1979); Disability (2371)
Event Date 03/18/2015
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. Without a lot number a review of the manufacturing records could not be conducted. Based on the information provided it is unclear what is meant when the surgeon alleged "a nerve was stuck to the mesh. " 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) 2014, the patient underwent implant of a bard mesh pre-shaped with keyhole to treat a left inguinal hernia. Allegedly the patient began experiencing excruciating left groin pain several months after the implantation. On (b)(6) 2015, the patient underwent excision of the bard mesh. Allegedly the surgeon noted that "a nerve stuck to the mesh. " the surgeon attempted to spare the nerve. However, "on mobilizing the nerve off the mesh, two things happened: the mesh was completely torn and the nerve was torn as well. " the surgeon then determined that the mesh had to be completely removed. The attorney alleges the patient experienced left groin pain, additional surgery, nerve damage, torn material, explant, adhesions and disability.
 
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Brand NameBARD MESH PRE-SHAPED
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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key6509153
MDR Text Key73331032
Report Number1213643-2017-00259
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2019
Device Catalogue Number0112710
Device Lot NumberHUYF1805
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 Received10/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2014
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: 04/20/2017 Patient Sequence Number: 1
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