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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH Back to Search Results
Catalog Number 5950007
Device Problems Defective Device (2588); Material Deformation (2976)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Disability (2371)
Event Date 09/28/2015
Event Type  Injury  
Manufacturer Narrative
There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. No medical records have been provided. The sample was not returned for evaluation, therefore we are unable to confirm the alleged condition of the implant. Based on the limited information provided at this time, no conclusions can be made. Inflammation and allergic reaction are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication. Should additional information be provided a supplemental emdr 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.
 
Event Description
The following was alleged by the patient's attorney: on (b)(6) 2013: the patient underwent surgery for repair of an incarcerated umbilical hernia. As reported, a bard/davol ventralex st hernia patch , reference number (b)(4), lot number huxd0590 was implanted to repair the hernia defect. On (b)(6) 2015: the patient underwent explant of the bard/davol ventralex st hernia patch. It is alleged that sometime after placement the device malfunctioned by, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response. It is alleged that as a result of these failures, the patient has suffered severe injuries, required substantial medical care, has suffered and will continue to suffer physical pain.
 
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Brand NameVENTRALEX ST
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 Key7152947
MDR Text Key96005757
Report Number1213643-2017-01128
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101928
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 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2015
Device Catalogue Number5950007
Device Lot NumberHUXD0590
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 Received12/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2013
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: 12/28/2017 Patient Sequence Number: 1
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