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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117321
Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2019
Event Type  malfunction  
Manufacturer Narrative
The most probable root cause is the mesh was damaged during use while the surgeon was attempting to insert it through the port. As reported this was not an out of box failure. The sample evaluation confirms the mesh was folded during manipulation prior to attempted deployment into the port. As received there is a visible fray/crack in the edge seal of the mesh. The section of the edge seal that is frayed/cracked corresponds with a fold line in the mesh. Based on the event as reported and sample condition, the fraying/cracking of the edge seal condition found inadvertently occurred during user/device interface while attempting to deploy the mesh through the port. The information provided by bd 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 bd.
 
Event Description
It was reported that there was a tear on the edge of the 3dmax mesh when the doctor attempted to insert it through the port. No patient injury.
 
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Brand Name3DMAX LIGHT
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 Key8753027
MDR Text Key149812038
Report Number1213643-2019-05692
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 07/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117321
Device Lot NumberHUCY0524
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2019
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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