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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 Consequences Or Impact To Patient (2199)
Event Date 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
At this time, no conclusion can be made. While the sample evaluation is anticipated it has not get begun. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2020. Review of the manufacturing records is in process. When the investigation has been completed, a supplemental emdr will be submitted.
 
Event Description
It was reported that on (b)(6) 2020, while preparing a ventralight st mesh to be opened in a sterile field, it was noted that the external packaging of the mesh was intact but upon opening, there was a hole in the sealed silver packaging around the actual mesh. As reported, there was no injury or impact to the patient. There was about a 5 minute or less delay to the case as another piece of mesh was procured to complete 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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10058370
MDR Text Key192488425
Report Number1213643-2020-04817
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5954450
Device Lot NumberHUEN1915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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