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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 Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The information provided is limited and the sample has not been returned. Requests for additional information, including sample return status have been made. Based on the information provided, and not having the sample to evaluated no conclusion can be made. It is unclear at this time what is meant by "the mesh began to fall apart" during attempted placement. However, typically this would indicate that the mesh was over or under hydrated causing an issue with the hydrogel (st) coating. Per the instructions-for-use the "ventralight ¿ st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement. If sutures are being placed, attach the sutures to the ventralight ¿ st mesh before hydration. The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating. " 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 production lot of (b)(4) units released for distribution in october, 2019. Should additional information be provided or if the sample is returned for evaluation, a supplemental emdr will be submitted.

 
Event Description

It was reported that "when the o. R. Staff attempted to place the bard ventralight st mesh inside the patient, the mesh began to fall apart. They were unable to continue using this particular mesh. The procedure was able to be completed using other mesh the surgery unit had on hand. " as reported, there was no patient injury.

 
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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 Key9457318
MDR Text Key193301672
Report Number1213643-2019-12027
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,USER F
Reporter Occupation
Type of Report Initial
Report Date 12/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5954450
Device LOT NumberHUDV0879
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/18/2019
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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