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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 MID; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX MID; SURGICAL MESH Back to Search Results
Catalog Number 0116312
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that a brown fiber was found on the 3dmax mid mesh.At this time, no conclusion can be made.While the sample evaluation is anticipated, it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 165 units released for distribution in september 2020.When sample evaluation is completed, a supplemental emdr will be submitted.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
As reported, during a robotic inguinal case on (b)(6) 2020, it was identified that a brown fiber was found on the 3dmax mid xl.The issue was noticed when the sterile packaging was opened prior to handing off to the or nurse in the sterile field.As reported, the mesh was not used, another mesh was brought into the case and the procedure was successfully completed.There was no reported patient injury.
 
Event Description
As reported, during a robotic inguinal case on (b)(6) 2020, it was identified that a brown fiber was found on the 3dmax mid xl.The issue was noticed when the sterile packaging was opened prior to handing off to the or nurse in the sterile field.As reported, the mesh was not used, another mesh was brought into the case and the procedure was successfully completed.There was no reported patient injury.
 
Manufacturer Narrative
It was reported that a brown fiber was found on the 3dmax mid mesh.At this time, no conclusion can be made.While the sample evaluation is anticipated, it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 165 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 device evaluation.The subject device was returned for evaluation.Visual inspection identified a brown fiber/ particle enclosed within the clam shell tray.Based on the investigation activities performed, the reported event is confirmed for foreign matter inside the sealed package.As the foreign matter was present in the package prior to sealing, this presented at the time of manufacturing and is confirmed for a manufacturing related condition.Sample evaluated.
 
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Brand Name
3DMAX MID
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
MDR Report Key10919424
MDR Text Key218706288
Report Number1213643-2020-20060
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741200762
UDI-Public(01)00801741200762
Combination Product (y/n)N
PMA/PMN Number
K200818
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/28/2022
Device Catalogue Number0116312
Device Lot NumberHUETAB07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Date Manufacturer Received11/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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