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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH - VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number UNKAA077
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Death (1802); Unspecified Infection (1930); Disability (2371)
Event Date 09/11/2018
Event Type  Death  
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges adverse patient outcomes associated with the hernia mesh used to treat the patient including death, permanent injury, infection and bowel obstruction. No medical records, autopsy report, or death certificate have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. The instructions-for-use (ifu) supplied with the device lists infection as possible complication. 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 patch. An unresolved infection may require removal of the device. ¿ this emdr represents the bard/davol mesh - ventralex (device #2). An additional emdr was submitted to represent the bard/davol kugel patch (device #1). Should additional information be provided, a supplemental emdr will be submitted.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard mesh (bard flat mesh), bard/davol kugel hernia patch and ventralex. As reported, the plaintiff is making a claim for an adverse patient outcome against the kugel hernia patch which was implanted on (b)(6) 2006 and ventralex which was implanted on (b)(6) 2012. Attorney alleges wrongful death of the patient. It is alleged that the patient passed away on (b)(6) 2018 from a severe infection and bowel obstruction caused by the negligence of the defendants. 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 NameMESH - VENTRALEX
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 Key10557942
MDR Text Key207680793
Report Number1213643-2020-08551
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
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: 09/20/2020 Patient Sequence Number: 1
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