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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 0117311
Device Problems Material Frayed (1262); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/23/2020
Event Type  Malfunction  
Manufacturer Narrative

As reported, 3dmax light mesh was found to be frayed and twisted upon opening the package. As reported the subject device is being returned for evaluation. However, at this time has not been received. Based on the available information, we are unable to determine a root cause for the reported event at this time. If/when the sample is received and evaluated, a supplemental mdr will be submitted.

 
Event Description

As reported, while opening the package of 3dmax light on (b)(6) 2020, the mesh was found to be frayed and twisted. 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 Key11162821
MDR Text Key226568295
Report Number1213643-2020-20099
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0117311
Device LOT NumberHUEQ1541
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/26/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/02/2020
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: 01/13/2021 Patient Sequence Number: 1
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