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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 0010216
Device Problems Contamination of Device Ingredient or Reagent (2901); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  malfunction  
Manufacturer Narrative
At this time, no conclusion can be made. Returned for evaluation were four (4) small round white pieces of the alleged foreign material found by the user within the product packaging. Preliminary evaluation finds the returned material is round and plastic in nature. Review of the returned sample is ongoing at this time. When the sample evaluation is completed, a supplemental mdr will be submitted. A review of manufacturing records shows product was manufactured to specification. To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in june, 2019.
 
Event Description
As reported, upon opening the package of the bard/davol ventrio mesh during a procedure on (b)(6) 2021, a "white foreign material" was noted within the inner package. As reported, no damage was noted on the outer package and the mesh was implanted in the patient. There was no reported patient injury.
 
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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
MDR Report Key12638717
MDR Text Key276605350
Report Number1213643-2021-20363
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K100229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0010216
Device Lot NumberHUDP1027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2019
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: 10/15/2021 Patient Sequence Number: 1
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