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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT; SURGICAL MESH Back to Search Results
Catalog Number 0117320
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
As reported, the 3dmax light mesh was folded and damaged prior to use.There was no reported patient injury.The subject device is being returned for evaluation.However, at this time has not been received.Based on the available information, we are unable to determine a definitive root cause for the reported event.To date this is the only reported complaint from this manufacturing lot.If/when the sample is received and evaluated, a supplemental mdr will be submitted.
 
Event Description
It was reported that on (b)(6) 2020, the 3dmax light medium right mesh was opened prior to the procedure and noted that the mesh was folded and damaged.The alleged damage was seen around the center of the mesh.The edge was damaged by the user when the mesh was grasped by forceps.The procedure was completed by using another mesh.There was no reported patient injury.
 
Manufacturer Narrative
As reported, the 3dmax light mesh was folded and damaged prior to use.There was no reported patient injury.The subject device is being returned for evaluation.However, at this time has not been received.Based on the available information, we are unable to determine a definitive root cause for the reported event.To date this is the only reported complaint from this manufacturing lot.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr was submitted to document the result the sample evaluation.Evaluation of the sample finds the mesh is contaminated with bodily fluids and is creased from handling and attempted deployment using forceps.There is a tear noted in the center of the mesh and along the edge as reported.Based on the sample evaluation, the reported condition is confirmed and caused by user/device interface during attempted placement of the mesh with forceps as reported.The instructions-for-use provided with the device states ¿use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force.¿ updated fields: b4, d10, g4, g7, h2, h3, h6, h10 note: section a through f - 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.H3 other text : sample evaluated.
 
Event Description
It was reported that on (b)(6) 2020, the 3dmax light medium right mesh was opened prior to the procedure and noted that the mesh was folded and damaged.The alleged damage was seen around the center of the mesh.The edge was damaged by the user when the mesh was grasped by forceps.The procedure was completed by using another mesh.There was no reported patient injury.
 
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Brand Name
3DMAX LIGHT
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
MDR Report Key11097627
MDR Text Key225488877
Report Number1213643-2020-20090
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031052
UDI-Public(01)00801741031052
Combination Product (y/n)N
PMA/PMN Number
K091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0117320
Device Lot NumberHUEQ0349
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2020
Date Manufacturer Received12/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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