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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRIO ST SURGICAL MESH Back to Search Results
Catalog Number 5950050
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Inflammation (1932); Hernia (2240); Disability (2371)
Event Date 08/13/2014
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, hernia recurrence, adhesions, inflammation and surgical intervention. The instructions-for-use supplied with the device lists hernia recurrence, adhesions, and inflammation as possible complications. Should additional information be provided, a supplemental emdr will be submitted.

 
Event Description

Attorney alleges that on or about (b)(6) 2012, the patient was implanted with a non-bard/davol mesh to repair an umbilical hernia. On or about (b)(6) 2014, the patient underwent repair of a recurrent hernia and a bard/davol ventrio st mesh was implanted during this repair. On or about (b)(6) 2014, the patient underwent additional revision surgery of the mesh products. It is alleged that the patient had experienced and/or continues to experience severe pain, inflammation, adhesions, and recurrence. 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 NameVENTRIO 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 Key11379420
MDR Text Key233531199
Report Number1213643-2021-01270
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2015
Device Catalogue Number5950050
Device LOT NumberHUXE0636
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/18/2013
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: 02/25/2021 Patient Sequence Number: 1
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