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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 SURGCIAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. MESH - VENTRALEX SURGCIAL MESH Back to Search Results
Catalog Number 0010301
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2015
Event Type  Malfunction  
Manufacturer Narrative

This initial mdr is being submitted as a result of a retrospective review of davol¿s mdr decision and the initial decision not to report the event is being revised to reflect updated company procedures. It was reported to davol, that the surgeon was performing an open umbilical hernia repair and as the ventralex mesh was "curled" for insertion into the patient, it was noted the ring had pulled away from the mesh. This mesh was set aside and another used to complete the repair no patient harm reported. The sample evaluation found that the inner stitch line sewing monofilament was loose/undone between the 9 and 12 o'clock position. Dimensional measurements were taken and ring placement position was observed and all were noted to be with specification. No manufacturing discrepancies were noted. A dhr review was conducted and found no discrepancies or anomalies during the manufacture of the subject lot, the product met specification and there was no rework that would cause or contribute to the complaint. The hernia repair section of the ifu states, "roll the patch parallel to the opening between the straps with the eptfe side facing out for insertion into the defect. Gently pull up on the positioning strap, which would allow the patch to flatten itself against the underside of the abdominal wall. " based on the information provided regarding the event indicating that the condition was observed as the mesh was "curled" would indicate the eptfe side of the mesh was facing in as it is not feasible to observe the reported condition when it is facing out. In doing so, this placed undue stress on the device and likely contributed to the reported condition.

 
Event Description

It was alleged the surgeon was performing an open umbilical hernia repair and as the ventralex mesh was "curled" for insertion into the patient, it was noted the ring had pulled away from the mesh. This mesh was set aside and another used to complete the repair, no patient harm reported.

 
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Brand NameMESH - VENTRALEX
Type of DeviceSURGCIAL 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 Key6746519
MDR Text Key81197625
Report Number1213643-2017-00459
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 07/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2018
Device Catalogue Number0010301
Device LOT NumberHUYL0128
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/07/2015
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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