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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954450
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The sample was not returned for evaluation, however the user facility provided photos of the device packaging. The photos show an opened ventralight st inner foil pouch. There are creases and indentations that can be identified on the pouch as would be typical of a pouch that had been opened. The user facility did not report a concern for the packaging as presented prior to opening the pouch. The photos do not allow us to determine if a sterile barrier breach presented. Creases and indentations on the foil pouch are conditions that can present during the opening of the pouch with no compromise of the sterile barrier. The sample was discarded by the user facility, as such no conclusion can be made. Discarded.
 
Event Description
It was reported that the hospital has concerns with how the foil pouch packaging of the ventralight st mesh looks after it is open and the mesh is removed. The concern is for compromised sterility. The contact stated it is hospital practice to hold the sterile pouch up to the light and visually examine before use. The implant was not used in the case.
 
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Brand NameVENTRALIGHT ST 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
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key8189728
MDR Text Key131185991
Report Number1213643-2018-04909
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2020
Device Catalogue Number5954450
Device Lot NumberHUCP2571
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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