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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number 0010302
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Hernia (2240); Disability (2371)
Event Date 03/20/2014
Event Type  Injury  
Manufacturer Narrative
To date, limited information has been provided. Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged. It was not identified if the device was explanted in either of the revision procedures. Hernia recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication. If additional information is obtained, a supplemental 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.
 
Event Description
It is alleged by the patients attorney that on (b)(6) 2013, the patient underwent surgery for repair of a supraumbilical ventral hernia. As reported, a bard/davol ventralex hernia patch mesh, reference number (b)(4), lot number huve0392 was implanted to repair the hernia defect. It is alleged that a year later on (b)(6) 2014, the patient underwent an additional surgery to revise/repair the recurrent ventral hernia. It is alleged that several months later on (b)(6) 2014, the patient underwent another additional surgery for chronic pain and recurrent ventral hernia repair. As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex hernia patch.
 
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Brand NameMESH VENTRALEX
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
jessica messier
100 crossings blvd.
warwick, RI 02886
4018258720
MDR Report Key7143923
MDR Text Key95692862
Report Number1213643-2017-01108
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021736
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 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2016
Device Catalogue Number0010302
Device Lot NumberHUVE0392
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received12/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2011
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: 12/22/2017 Patient Sequence Number: 1
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