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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 SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX SURGICAL MESH Back to Search Results
Catalog Number 0115321
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the bard/davol 3dmax mesh was noted to be frayed prior to use. The subject device was discarded by the user facility and not available for evaluation. Based on the information available and without having the sample to evaluate, no conclusion can be made. Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported. To date, this is the only reported complaint for this manufacturing lot of 1496 units released for distribution in (b)(6) 2021. Should additional information be provided, a supplemental mdr will be submitted.
Event Description
As reported, during a robotic inguinal hernia repair on (b)(6) 2021, it was noted that a bard/davol 3dmax mesh was frayed prior to use. There was no damage noted to the packaging prior to opening. It was reported that another 3dmax mesh was used to complete the procedure. There was no patient injury.
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Brand Name3DMAX
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
MDR Report Key12130077
MDR Text Key260690431
Report Number1213643-2021-20176
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0115321
Device Lot NumberHUFP0789
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2021
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: 07/07/2021 Patient Sequence Number: 1