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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRIO MESH SURGICAL MESH Back to Search Results
Catalog Number UNKAA079
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348); Disability (2371)
Event Type  Injury  
Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges "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"; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. Should additional information be provided, a supplemental emdr will be submitted. Not returned.

 
Event Description

Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventrio on (b)(6) 2014. As reported, the patient is making a claim for an adverse patient outcome against the ventrio. 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 patient experienced emotional distress and the device was defective.

 
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Brand NameVENTRIO MESH
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 Key11371589
MDR Text Key233249030
Report Number1213643-2021-01167
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 02/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA079
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 02/24/2021 Patient Sequence Number: 1
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