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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 5954600
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/16/2019
Event Type  Malfunction  
Manufacturer Narrative

A definitive root cause is undetermined. The sample as received was stuck to the inside of the inner tyvek retainer. The mesh itself was inside of the retainer and had to be removed by slowly peeling back the retainer as the mesh is still extremely tacky from being hydrated. This caused the hydrogel material to stick to the retainer. Sutures were placed in the mesh during preparation for use, however, it is unknown if the sutures were placed prior to hydration. Due to the condition of the physical sample the photo provided by the customer was used for the evaluation. Evaluation of the photo provided confirms the reported event. The photo provided shows the hydrogel has separated as reported. Based on the available information and condition of the sample a definitive conclusion cannot be determined. It is likely that hydrogel may have been overhydrated and subsequent handling of the mesh inadvertently damaged the hydrogel barrier. No manufacturing anomalies were found. 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 167 units released for distribution in may, 2017.

 
Event Description

It was reported that on (b)(6) 2019 a bard ventralight st mesh was being prepared for a laparoscopic ventral hernia repair procedure. As reported the mesh was hydrated in saline for 4-5 seconds and then is was noted that the "seprafilm barrier scraped off before inserting it into the trocar. " the mesh was not used, another mesh was used to complete the case. There was no patient injury reported.

 
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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 Key8596601
MDR Text Key145114791
Report Number1213643-2019-03724
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 05/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/09/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2019
Device Catalogue Number5954600
Device LOT NumberHUBQ0399
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/30/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2017
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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