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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 UNKAA077
Device Problems Defective Device (2588); Folded (2630)
Patient Problems Hernia (2240); Injury (2348); Disability (2371)
Event Date 08/27/2013
Event Type  Injury  
Manufacturer Narrative

Based on the information provided we are unable to determine to what extent, if any the bard ventralex hernia patch mesh (device #1) 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 remove the ventralex hernia mesh patch which was noted by the operating surgeon to have "folded on itself. " medical records are not available at this time, 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. No lot number has been provided; therefore a review of the manufacturing records is not possible at this time. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard ventralex mesh (device #1) implanted on (b)(6) 2009. An additional emdr was submitted to represent the bard composix l/p (device #2) implanted on (b)(6) 2013. 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 a recurrent incisional abdominal hernia. A bard/davol ventralex hernia patch mesh (device #1) was implanted to repair the hernia defect. On (b)(6) 2013: the patient underwent an additional surgery to remove the ventralex hernia mesh patch which was noted by the operating surgeon to have "folded on itself. " on (b)(6) 2013: the patient was implanted with a bard/davol composix l/p mesh (device #2) to repair a ventral hernia defect and to replace the failed ventralex hernia mesh patch from the patient's previous surgery. On (b)(6) 2015: the patient underwent an additional surgery to repair the hernia defect and to remove the composix l/p mesh. As reported, the operating surgeon noted that the composix mesh had tracked away from its position and pulled away from the left side completely and was "balled up along the right side. " and the failed composix l/p was replaced with "another mesh device. " 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 and composix l/p 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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key7252949
MDR Text Key99567573
Report Number1213643-2018-00240
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK021736
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 02/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA077
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 Received01/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/08/2018 Patient Sequence Number: 1
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