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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); Material Deformation (2976); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fibrosis (3167)
Event Type  Injury  
Event Description
Attorney alleges that on or about (b)(6) 2019, patient was implanted with a bard/davol ventrio st mesh. It is alleged that the device was defective, had the propensity to contract or shrink inside the body, that in turn causes surrounding tissue to be inflamed, become fibrotic, and contract, resulting in injury; had the propensity to "creep", or to gradually elongate and deform when subject to prolonged tension inside the body; the inelasticity of the medical device, causing it to be improperly mated to the delicate and sensitive areas of the vagina and pelvis where they are implanted, and causing pain upon normal daily activities that involve movement in the pelvic region (e. G. , intercourse, defecation, walking); the propensity of the medical device for degradation or fragmentation over time, which causes a chronic inflammatory and fibrotic reaction, and results in continuing injury over time; and the creation of non-anatomic condition in the pelvis leading to chronic pain and functional disabilities when the mesh is implanted. Attorney alleges that as a direct and proximate result of the above foregoing defective and unreasonably dangerous conditions, the patient suffered a migration and infection from the implanted mesh causing numerous internal injuries, infection, and patient suffered injury to the body as a whole and sustained constant pain and suffering.
 
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, mesh migration, deformation, infection, pain and injury. The instructions-for-use (ifu) supplied with the device lists infection as a possible complication. 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.
 
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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 Key13200793
MDR Text Key284183248
Report Number1213643-2021-09618
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 Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2021
Device Catalogue Number5950050
Device Lot NumberHUDT0024
Was Device Available for Evaluation? No
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2019
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: 01/08/2022 Patient Sequence Number: 1
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