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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 0010302
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2015
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 by the customer's facility, that the ring of the ventralex mesh separated from the mesh during the procedure while positioning of the device. It was indicated that the mesh was removed and the procedure was successfully completed using another ventralex patch without harming the patient. Based on the evaluation of the returned sample, a small segment of the inner stitch line sewing monofilament that secures the ring containment sleeve was confirmed to be loose and out of the stich holes at the upper mesh slit area. The ring and containment sleeve were fully intact. The eptfe presented with holes which indicated the stitching was executed and inner sewing line was present at the time of manufacture. Additionally, in the as received condition, the mesh was noted to be in a convex orientation with the mesh on the outward facing side and the eptfe on the inward facing side with one area having evidence of a fold present in the same direction. This condition may have been associated with the mesh having been prepared for insertion into the patient with the eptfe side facing in. Also, it is possible for the inner stich line sewing monofilament to be inadvertently cut during placement of the patch causing it to become loose. 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. " if rolled in the direction opposite of the ifu, this could place undue stress on the device and potentially contribute to the reported condition. At this time no definitive root cause was identified; however, it may be associated with the operator's technique or use environment.

 
Event Description

It was reported by the facility, that the ring of the ventralex mesh separated from the mesh during positioning of the device. The mesh was removed and the procedure was successfully completed using another ventralex without any harm reported to the 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 Key6746708
MDR Text Key81150677
Report Number1213643-2017-00464
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 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 Date06/30/2018
Device Catalogue Number0010302
Device LOT NumberHUYK1052
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/06/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/25/2014
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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