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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the edge seal of the bard/davol 3dmax light mesh was damaged upon opening the package.It is reported that the mesh is being returned for evaluation; however at this time has not been received.Based on the information provided to date, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint reported from this manufacturing lot of (b)(4) units released for distribution in september, 2020.When/if the sample is returned and evaluated and/or additional information is provided, a supplemental mdr will be submitted.
 
Event Description
As reported, when opening the package of the bard/davol 3dmax light mesh on (b)(6) 2021, it was noted that the edge seal part of the mesh was damaged.The mesh was not used on the patient.There was no reported patient injury.
 
Event Description
As reported, when opening the package of the bard/davol 3dmax light mesh on (b)(6) 2021, it was noted that the edge seal part of the mesh was damaged.The mesh was not used on the patient.There was no reported patient injury.
 
Manufacturer Narrative
As reported, the edge seal of the bard/davol 3dmax light mesh was damaged upon opening the package.It is reported that the mesh is being returned for evaluation; however at this time has not been received.Based on the information provided to date, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint reported from this manufacturing lot of (b)(4) units released for distribution in september, 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the photo evaluation.Review of the intraoperative photos provided shows the mesh in vivo being manipulated and pulled on with two surgical graspers.The photos show an edge seal tear in the area the mesh in being manipulated and pulled on during placement.Based on the photos provided and investigation performed, the cracking/tearing of the edge seal is the result of forces applied and inadvertently occurred during user/device interface while deploying the mesh and manipulation with surgical tools.Updated fields: b4, d9, g3, g6, 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 : not returned.
 
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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 Key12377714
MDR Text Key268479679
Report Number1213643-2021-20278
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 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0117320
Device Lot NumberHUEV0911
Was Device Available for Evaluation? No
Date Manufacturer Received09/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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