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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO MESH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO MESH SURGICAL MESH Back to Search Results
Catalog Number 0010217
Device Problems Material Separation (1562); Patient-Device Incompatibility (2682)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 05/01/2021
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, no conclusion can be made. As reported, approximately 10 years post-implant of the ventrio mesh, the patient experienced abdominal abscess and infection, and underwent surgical intervention with partial explant of the mesh. The surgeon notes that the mesh had ¿started separating. ¿ review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may, 2011. Regarding infection the warnings section of instructions for use (ifu) supplied with this device states: "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " note the reported date of implant is prior to the release of the reported product code/lot number for distribution. If/when additional information is received a supplemental mdr will be submitted. Not returned.
 
Event Description
On (b)(6) 2011- the patient underwent incisional hernia repair with implant of a bard/davol x-large ventrio mesh. In (b)(6) 2021 - the patient returned two weeks before (b)(6) 2021 with an abdominal abscess. On (b)(6) 2021 - the surgeon performed an exploratory laparotomy and discovered that the mesh had separated from the layers. As reported, "the surgeon stated that the mesh had started separating and he thinks this caused an infection. " as reported, the surgeon felt that mesh was possibly defective and should not have separated. The remnant of the mesh was sent to pathology. As reported, the patient is doing well and was discharged to home.
 
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Brand NameVENTRIO MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
8005566756
MDR Report Key11966894
MDR Text Key255134578
Report Number1213643-2021-20142
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2014
Device Catalogue Number0010217
Device Lot NumberHUVE0919
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2011
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: 06/09/2021 Patient Sequence Number: 1
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