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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX SURGICAL MESH Back to Search Results
Catalog Number 0115321
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The sample evaluation confirms for the reported condition of a hole in the mesh. Additionally, the mesh appears to have been stretched and there was fraying of the outer edges. It was reported that the damage was noted when the package was opened, however the evaluation identifies physical damage to be consistent with a user device interface event. It appears that the hole in the mesh and the fraying of the outer edges may have been caused by a combination of user handling stretching the mesh and possibly a grasper. The method of insertion is to roll up the mesh and hold it with a grasper to present through a trocar or into the body directly. A review of the manufacturing records was performed and found that the lot was manufactured to specification. 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

It is reported that a hole was noted in the 3dmax mesh. As reported the hole was noted when the package was opened. There is no reported damage to the outer or inner package. There was no patient injury.

 
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Brand Name3DMAX
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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7327695
MDR Text Key102094418
Report Number1213643-2018-00521
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 03/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0115321
Device LOT NumberHUBX1161
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/08/2017
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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