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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 0010211
Device Problems Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008)
Patient Problem Pain (1994)
Event Date 03/16/2015
Event Type  Injury  
Manufacturer Narrative
As reported post implant of a bard/davol ventrio mesh, the patient was involved in a car accident and several falls which resulted in the mesh tearing loose. In addition, it was reported that post implant. The patient complained of severe pain which led to an unspecified revision surgery. Based on the available information, it is unclear if the pain and revision surgery occurred prior to, or after the car accident and falls. It was also reported that the patient had recently passed away due to multiple non-device related complications including covid-19, septic shock, and copd. It was reported that the mesh remained implanted at the time of the patient¿s death. No medical records, autopsy report, or death certificate have been provided. Based on the available information, no conclusions can be made. Pain is a known inherent risk of any surgical procedure. Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the patient¿s reported postoperative course. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november, 2014. Note, the date of event provided ((b)(6) 2015) is estimated based on the allegation statement of the patient¿s pain post implant. Should additional information be provided, a supplemental mdr will be submitted.
 
Event Description
As reported, the patient underwent surgery for implant of a bard/davol ventrio mesh on (b)(6) 2015, but the mesh had torn loose after a car accident and several falls. Post-implant, the patient had repeated complaints of severe pain that led to a revision surgery. As reported, the patient died on (b)(6) 2021 due to covid-19, septic shock, and chronic obstructive pulmonary disease (copd).
 
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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 Key11819248
MDR Text Key250439740
Report Number1213643-2021-20114
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 consumer,other
Reporter Occupation
Type of Report Initial
Report Date 05/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2017
Device Catalogue Number0010211
Device Lot NumberHUYI2010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2014
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: 05/13/2021 Patient Sequence Number: 1
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