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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 0117311
Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/25/2019
Event Type  malfunction  
Manufacturer Narrative
The most probable root cause is the mesh was damaged during use. Visual evaluation of the sample finds that the mesh has been folded/rolled prior to attempted implantation. 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. A review of the manufacturing records was performed and found that the lot was manufactured to specification.
 
Event Description
It was reported that on (b)(6) 2019 the bard 3dmax light mesh was noted to be damaged. Another 3dmax light mesh was used to complete the case. There was no patient injury reported.
 
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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 Key8912732
MDR Text Key155026818
Report Number1213643-2019-07236
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
Reporter Occupation
Type of Report Initial
Report Date 08/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117311
Device Lot NumberHUDQ0653
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2019
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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