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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 0010303
Device Problems Defective Component (2292); Patient-Device Incompatibility (2682)
Patient Problems Hernia (2240); Injury (2348); Disability (2371)
Event Date 02/07/2012
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. 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. Not returned.
 
Event Description
It is alleged by the patients attorney that on (b)(6) 2010, the patient underwent surgery for repair of an incisional ventral hernia. As reported, a bard/davol ventralex hernia patch mesh, (b)(4), lot number huug2256 was implanted to repair the hernia defect. It is alleged that on (b)(6) 2017, the patient underwent an additional surgery to repair the hernia defect and remove the ventralex hernia patch because the mesh was defective, failed and "caused damage to her internal organs. " 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 Key7143363
MDR Text Key95658165
Report Number1213643-2017-01105
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024008
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 Date08/28/2015
Device Catalogue Number0010303
Device Lot NumberHUUG2256
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 Manufactured11/17/2010
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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