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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 0117310
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, a piece of the 3dmax light mesh fell into the patient's abdomen, during insertion through the trocar.The mesh sample was not returned, as such we are unable to determine the cause of the reported issue.Based on the available information and not having the sample to evaluate, no conclusion can be made.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november, 2020.The instructions for use supplied with the device states "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force." if additional information/sample is provided, a supplemental mdr will be submitted.
 
Event Description
As reported, during a procedure on (b)(6) 2021, during insertion of a bard/davol 3dmax light mesh through a trocar, a piece of mesh fell into the patient's abdomen.It is reported that it is unclear to the user whether the piece of mesh found, tore off the mesh during insertion, or if it was on the device and fell off during insertion.As reported, the mesh piece and device were removed from the patient.There was no reported patient injury.
 
Event Description
As reported, during a procedure on (b)(6) 2021, during insertion of a bard/davol 3dmax light mesh through a trocar, a piece of mesh fell into the patient's abdomen.It is reported that it is unclear to the user whether the piece of mesh found, tore off the mesh during insertion, or if it was on the device and fell off during insertion.As reported, the mesh piece and device were removed from the patient.It was reported that a bard/davol 3dmax light mesh was not implanted to the patient and there was no damage was noticed on the outer package.There was no reported patient injury.
 
Manufacturer Narrative
As reported, a piece of the 3dmax light mesh fell into the patient's abdomen, during insertion through the trocar.The mesh sample was not returned, as such we are unable to determine the cause of the reported issue.Based on the available information and not having the sample to evaluate, no conclusion can be made.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution on (b)(6) 2020.The instructions for use supplied with the device states "use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force." addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the sample evaluation.Returned for evaluation was a pieced of the edge seal that had been torn away from the mesh.A photo of the edge seal was also provided.Based on the sample evaluation and investigation performed, the edge seal most likely tore from the mesh with forces applied during user/ device interface while deploying through the trocar.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 : sample evaluated.
 
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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 Key12274761
MDR Text Key264977470
Report Number1213643-2021-20220
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031021
UDI-Public(01)00801741031021
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,foreig
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0117310
Device Lot NumberHUEX0010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Initial Date Manufacturer Received 07/13/2021
Initial Date FDA Received08/04/2021
Supplement Dates Manufacturer Received08/18/2021
Supplement Dates FDA Received09/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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