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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH Back to Search Results
Catalog Number UNKAA086
Device Problems Material Separation (1562); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2018
Event Type  Malfunction  
Manufacturer Narrative

Based on the event as reported, the user experienced difficulty when attempting to fixated the mesh, which caused small tears in the hydrogel barrier only. As reported the mesh was implanted in the patient and the surgeon states this event did not "affect the integrity of the mesh. " this was not reported an out of box event and there is no indication that nonconforming product was provided to the customer. The hydrogel barrier is designed to be completely resorbed from the site within 30 days of implant. The mesh remains implanted and there has been no reported patient injury as a result of this event. A lot number was not provided therefore a review of the manufacturing records is not possible. Should additional information be provided, a supplemental emdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Remains implanted.

 
Event Description

As reported per facility contact on or about (b)(6) 2018 a ventralex st implant was damaged during placement. It was reported that the implant was torn during fixation with optifix. In follow up with the surgeon it was later stated that there were a few, ¿small tears¿ on the posterior side or the mesh, which in his opinion did not affect the integrity of the mesh. The device was implanted. The tears are roughly the diameter of a fastener. The tm explained to the surgeon the pga component layer over the polypropylene mesh. The surgeon believes the area he describes as torn was pga material separation and not torn polypropylene mesh.

 
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Brand NameVENTRALEX ST
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 Key7730923
MDR Text Key115358967
Report Number1213643-2018-02531
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101928
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 07/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA086
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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