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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 Device (2588); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 08/29/2013
Event Type  Injury  
Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, mesh detachment, coiling, hernia recurrence, adhesions and inflammation. The instructions-for-use supplied with the device lists hernia recurrence, adhesions, and inflammation as possible complications. 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. Not returned.

 
Event Description

Attorney alleges that on or about (b)(6) 2013, the patient underwent repair of a ventral hernia and a bard/davol ventralex mesh patch was implanted to repair the hernia defect. The patient underwent revision surgery on or about (b)(6) 2013. It is alleged that on or about (b)(6) 2014, the patient underwent an additional revision surgery and a non-bard/davol mesh was implanted during the procedure. The patient underwent further revision surgery of the mesh products on or about (b)(6) 2016. Attorney also alleges that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, mesh detachment, recurrence, dense adhesions and mesh coiling. Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. " it is also alleged that the device was defective.

 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key11374416
MDR Text Key233465644
Report Number1213643-2021-01197
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
Type of Report Initial
Report Date 02/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2018
Device Catalogue Number0010303
Device LOT NumberHUXA0678
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/04/2013
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: 02/24/2021 Patient Sequence Number: 1
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