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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.
 
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Brand Name3DMAX MID
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
8005566756
MDR Report Key10919424
MDR Text Key218706288
Report Number1213643-2020-20060
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200818
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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
Device Catalogue Number0116312
Device Lot NumberHUETAB07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/30/2020 Patient Sequence Number: 1
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