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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2 SURGICAL MESH Back to Search Results
Catalog Number 5991520
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the st coating peeled about 1-2 mm from the edge of the bard/davol ventralight st w / echo 2 mesh. Information regarding mesh preparation including mesh hydration and trocar size used were not provided. Based on the information provided and without having the sample available for evaluation, no conclusions can be made. Review of manufacturing records confirms 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 from this manufacturing lot of (b)(4) units released for distribution in july, 2021. Should additional information be provided, a supplemental mdr will be submitted. Not returned - remains implanted.
 
Event Description
As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2021, it was noted that the st coating peeled about 1-2 mm from the edge of the bard/davol ventralight st w / echo 2 mesh. As reported, the surgeon used a couple of additional fasteners/fixation to secure the st coating in place, over the mesh. As reported, there was no patient harm or injury as a result and the surgeon completed the case without any further issue.
 
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Brand NameVENTRALIGHT ST W/ ECHO 2
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 Key12591024
MDR Text Key275197515
Report Number1213643-2021-20348
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170294
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 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5991520
Device Lot NumberHUFS1711
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 Received09/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2021
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: 10/07/2021 Patient Sequence Number: 1
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