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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 0117321
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the bard/davol 3dmax light mesh was "cracked" upon removing from the package. The event was reported as an out of box observation. The sample has not been returned for evaluation. Review of manufacturing records indicate product was manufactured to specification. Based on the information available and without having the sample to evaluate, no conclusion can be made. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august, 2019. If/when sample is received and evaluated, a supplemental emdr will be submitted. Not returned.
 
Event Description
As reported, during an unknown procedure, the bard/davol 3dmax light mesh was noted to be "cracked" when removed from the product packaging. The mesh was not used and there was no reported patient injury.
 
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Brand Name3DMAX LIGHT
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 Key12145593
MDR Text Key260873882
Report Number1213643-2021-20182
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091659
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 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117321
Device Lot NumberHUDT2060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2019
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: 07/09/2021 Patient Sequence Number: 1
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