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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 MESH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954600
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  Malfunction  
Manufacturer Narrative

As reported, it is alleged that while attempting to implant a ventralight st mesh, it "did not look right". The subject device was returned for evaluation. Sample evaluation finds the st coating has separated from areas on the mesh. The separation has resulted in a void of the hydrogel barrier. No manufacturing anomalies were found. Initial evaluation identified that the mesh had been hydrated by the user, how long the mesh had been hydrated for is unknown. The instructions-for-use states the mesh should be hydrated for no more than 1-3 seconds prior to use and rolled immediately to protect the bioresorbable coating. Based on the event as reported and sample evaluation a definitive root cause of the reported event cannot be made. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date this is the only reported complaint for this manufacturing lot. Note, the date of event provided is the best estimate based on the date of awareness of the reported event.

 
Event Description

It was reported that, during a hernia repair procedure, the ventralight st, "did not look right" and the product was deemed unusable. As reported, the or staff used another ventralight st mesh for the case without any issue. There was no reported patient harm/injury.

 
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Brand NameVENTRALIGHT ST 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 Key10784340
MDR Text Key214539605
Report Number1213643-2020-20028
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5954600
Device LOT NumberHUDQ0828
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/14/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2019
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: 11/04/2020 Patient Sequence Number: 1
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