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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH -VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number 0010301
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2016
Event Type  Malfunction  
Manufacturer Narrative

This initial mdr is being submitted as a result of a retrospective review of davol¿s mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures. The returned sample was received with the pdo ring containment sleeve partially separated from the mesh, and the pdo ring broken with significant degradation. Contact with the user facility reported that prior to being returned for evaluation, the sample was put through a washer decontaminator with an enzyme detergent and drying cycle. Soaking of a control sample in an enzyme detergent confirmed the condition of the pdo ring was the result of the enzyme wash. The sample evaluation regarding the partially separated pdo containment sleeve was limited due to the enzyme was and drying process. However, based on the evaluation and manufacturing review it appears that when attempting to position the device, forces applied by the user inadvertently caused the pdo ring containment sleeve to become partially separated from the device. 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.

 
Event Description

Per customer contact: alleged during use of the ventralex patch "the ring separated on more than half of the patch. " the case being performed was an open umbilical hernia repair and "the mesh had 3 sutures placed, 9-12-3 o'clock. The patch was then inserted into the hernia opening and the tabs were pulled to set the patch against the abdominal wall, shortened and separated. The mesh was then tented to place the 6 o'clock suture and the ring was discovered to be entirely uncovered and detached from the patch. The patch was removed and replaced with another patch of the same kind. " no patient injury.

 
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Brand NameMESH -VENTRALEX
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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key6745820
MDR Text Key81157294
Report Number1213643-2017-00458
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 07/26/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2019
Device Catalogue Number0010301
Device LOT NumberHUAP0788
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/14/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2016
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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