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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.
 
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, 5.4 x 7 in., was implanted during this repair.On or about (b)(6) 2014, the patient underwent additional revision surgery of the mesh products.The eptfe bard mesh implanted in patient failed to reasonably perform as intended and had to be surgically removed necessitating further invasive surgery.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.
 
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.Addendum: h11: this is an addendum to the initial emdr submitted.This supplemental emdr is submitted to report the correct event description regarding mesh explant omitted in the initial emdr and the corrected brand name.Updated fields: b4, g3, g6, h2, h6, h10, h11.Corrected fields: b5 (event description), d1 (brand name).Should additional information be provided, a supplemental emdr will be submitted.Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned.
 
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Brand Name
VENTRIO ST
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key11379420
MDR Text Key233531199
Report Number1213643-2021-01270
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031540
UDI-Public(01)00801741031540
Combination Product (y/n)N
PMA/PMN Number
K101920
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 02/04/2021
Initial Date FDA Received02/25/2021
Supplement Dates Manufacturer Received02/26/2021
Supplement Dates FDA Received03/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
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