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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 5950030
Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
Patient Problems Abscess (1690); Unspecified Infection (1930); Necrosis (1971); Hernia (2240)
Event Date 09/30/2013
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 disability, hernia recurrence, infection, abscess and subsequent surgical intervention for mesh removal. The instructions-for-use (ifu) supplied with the device lists hernia recurrence, infection, adhesions, inflammation 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 warnings section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. " should additional information be provided, a supplemental emdr will be submitted. Not returned.
 
Event Description
Attorney alleges that on or about (b)(6) 2012, the patient underwent repair of an abdominal hernia and was implanted with a bard/davol ventrio st mesh. It is alleged that on or about (b)(6) 2013 and (b)(6) 2014, the patient underwent additional surgeries to revise the ventrio st mesh. Attorney alleges that on or about (b)(6) 2015, the patient underwent surgery to revise the ventrio st mesh and a non-bard/davol mesh was implanted during this procedure. It is alleged that on or about (b)(6) 2019, the patient underwent additional surgeries to partially remove the mesh products. It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, torn mesh, dense adhesions, mesh detachment, infection, ulceration, dense scarring, open draining wound, abdominal wall reconstruction, necrosis, abscess, and recurrence. It is alleged that the patient is at a higher risk of severe complications during an abdominal surgery, to the extent that future abdominal operations might not be feasible. Attorney alleges that the ventrio st mesh implanted in patient failed to reasonably perform as intended, caused serious injury and had to be surgically removed via invasive surgery, and necessitating additional invasive surgery to repair the hernia that the ventrio st mesh was initially implanted to treat. Attorney alleges past, present, and future damages, that the patient has been injured, sustained severe and permanent pain, suffering, disability, impairment, mental anguish and emotional distress. 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 Key12661821
MDR Text Key277476988
Report Number1213643-2021-08196
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2013
Device Catalogue Number5950030
Device Lot NumberHUVH0741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2011
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: 10/19/2021 Patient Sequence Number: 1
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