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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3D MAX MESH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. 3D MAX MESH SURGICAL MESH Back to Search Results
Catalog Number 0115321
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2015
Event Type  Malfunction  
Manufacturer Narrative

Although we anticipate the return of the device for evaluation, at this time the sample has not been received. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released to production in 03/2013. Based on the available information, and having no sample returned, we are unable to evaluate for root cause or confirm the reported product problem. As reported the problem occurred while placing the mesh in the body with a grasper and this may have presented from device to device interface. If/when the sample is returned and evaluated a supplemental mdr 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. Not yet returned.

 
Event Description

The following was reported to davol: it has been reported that during a bilateral tep meshplasty the right sided 3dmax mesh tore while attempting to introduce into the body. As reported the mesh was handled with an atraumatic grasper, folded and inserted using the proper technique. Another 3dmax mesh was used to complete the case without issue.

 
Manufacturer Narrative

The sample was returned for evaluation. Visual examination of the mesh finds one area to have torn mesh material. The outer sealed edges are in good condition with no damage noted. As reported the problem presented only after the mesh was placed into the body. As such the torn mesh was not an out of box condition. Based on the event as reported and physical condition it appears that the mesh was inadvertently damaged during placement. Root cause appears to be related to user/device interface.

 
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Brand Name3D MAX MESH
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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5116230
MDR Text Key27202972
Report Number1213643-2015-00337
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device Catalogue Number0115321
Device LOT NumberHUXC0927
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/23/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/23/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/28/2013
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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