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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 5950080
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Hernia (2240); Disability (2371); Obstruction/Occlusion (2422)
Event Date 09/17/2018
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 permanent injury, hernia, adhesions, bowel injury, hematoma and recurrence. The instructions-for-use supplied with the device lists adhesions, hematoma and recurrence as possible complications. A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification. Should additional information be provided, a supplemental emdr will be submitted.

 
Event Description

Attorney alleges that the patient underwent surgery for a repair of a midline incisional hernia and a bard/davol ventrio st hernia patch was implanted on or about (b)(6) 2015. The patient underwent revision surgery of the ventrio st and was implanted with non-bard/davol mesh to repair a recurrent hernia on or about (b)(6) 2018. The patient underwent revision surgery of the mesh products on or about (b)(6) 2018. It is alleged that the patient continues to experience complications related to the mesh products, including severe and chronic pain/discomfort, adhesions to the bowel, bowel blockage, hematoma, and recurrence, and will likely require additional surgeries to repair the damage from the mesh products if the complications continue. 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 Key11380657
MDR Text Key239442367
Report Number1213643-2021-01311
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
Report Date 02/25/2021
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 Date12/28/2015
Device Catalogue Number5950080
Device LOT NumberHUXL0810
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 Manufactured12/26/2013
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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