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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 5950008
Device Problems Defective Device (2588); Material Deformation (2976); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Hernia (2240); Disability (2371)
Event Date 03/12/2018
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 contracted mesh, permanent injury, hernia recurrence, infection and surgical intervention. The instructions-for-use supplied with the device lists adhesions, infection and hernia recurrence as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the mesh. " this emdr represents the bard/davol ventralex st (device #1). An additional emdr was submitted to represent the bard/davol ventralex st (device #2). Should additional information be provided, a supplemental emdr will be submitted. Not returned.

 
Event Description

Attorney alleges that, on or about (b)(6) 2016, the patient underwent surgery for a repair of two ventral hernias and one umbilical hernia. A ventralex st was implanted to repair both ventral hernia defects. On or about (b)(6) 2018, the patient underwent surgery for a complete mesh explantation and for the repair of recurrent incisional hernia. On or about (b)(6) 2018, a ventralex st was implanted. It is alleged that there was an evidence of multiple adhesions and an infected, contracted composite mesh. The mesh was completely removed. It is alleged that the patient was injured severely and permanently. The patient suffered pain, disability, hospitalizations and additional surgeries. It is also alleged that the patient has suffered and will continue to suffer physical pain, chronic pain, mental anguish, psychological stress, depression, has undergone and will likely require medical treatments and other forms of care. Attorney also alleges that the device was defective.

 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10694758
MDR Text Key211872918
Report Number1213643-2020-09480
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2018
Device Catalogue Number5950008
Device LOT NumberHUAN1536
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/20/2016
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: 10/18/2020 Patient Sequence Number: 1
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