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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 Problems Material Frayed (1262); Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2016
Event Type  Malfunction  
Manufacturer Narrative

It was reported that the mesh straps came loose from the mesh. The device was not used, another device was used to complete the repair. The sample was returned to davol for evaluation. The pdo ring was not returned with the sample. The straps were attached to the sample with minor fraying noted, there were grasper marks seen on the eptfe. Stitch holes were present as well as a piece of monofilament, evidence of the inner sew line being present. It appears that forces applied during deployment were sufficient to separate the monofilament resulting in material separation of the mesh layers resulting in the separation of the pdo ring from the device. Based on the sample evaluation it appears that when attempting to position the device, forces applied by the user inadvertently caused damaged to the device. This is the only reported complaint for this manufacturing lot of 264 units.

 
Event Description

It was reported that the mesh straps get loose from the mesh and the straps were disintegrated. It was not possible to use the product. Another device has been placed on patient.

 
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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 Key6745788
MDR Text Key81147952
Report Number1213643-2017-00457
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK024008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
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 NumberHUAN1560
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/03/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
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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