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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); Insufficient Information (3190)
Patient Problems Pain (1994); Hernia (2240); Disability (2371)
Event Date 06/11/2015
Event Type  Injury  
Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the bard device may have caused or contributed to the events as alleged by the patient¿s attorney. The information provided alleges that the, "patient underwent an additional surgery to repair the hernia defect and remove it. " medical records were not provided and the description does not clearly define what "remove it" is referring to (example possible mesh explant, partial explant, or removal/repair of the hernia defect itself without explant of previously placed mesh). As such at this time, we have not identified this as reported device explant. Additionally, it is unclear at this time if the hernia defect repaired post implant of the mesh, was a recurrence of the original hernia defect or a new hernia defect, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard device implanted on (b)(6) 2014 (device #2). An additional emdr was submitted to represent the bard device implanted on (b)(6) 2009 (device #1). 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

The following was alleged by the patient's attorney: on (b)(6) 2009: the patient underwent surgery for repair of an incisional hernia. A bard/davol ventralex st hernia patch, reference number 5950007 and lot number huti1030 (device #1), was implanted to repair the hernia defect. On (b)(6) 2014: the patient underwent a second repair of an incisional hernia. A bard/davol ventralex st hernia patch, reference number 5950007 and lot number huyf1416 (device #2), was implanted to repair the hernia defect. On (b)(6) 2015: the patient underwent an additional surgery to repair the hernia defect and "remove it. " 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 st hernia patch.

 
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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 Key7150660
MDR Text Key95916826
Report Number1213643-2017-01116
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101928
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 HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2016
Device Catalogue Number5950007
Device LOT NumberHUYF1416
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 Received12/08/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/28/2014
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: 12/28/2017 Patient Sequence Number: 1
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