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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX LIGHT SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117311
Device Problems Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2019
Event Type  Malfunction  
Manufacturer Narrative

The sample was not returned for review and the information provided is limited. Additional information has been requested. A review of the manufacturing records was performed and found that the lot was manufactured to specification. No manufacturing issues associated to the alleged incorrect packaging were found in the reviewed lot. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in february 2019. At this time, there is no identification of a problem with the device, however no definitive conclusion can be made as to the cause of the problem reported. Should additional information be provided, a supplemental emdr will be submitted.

 
Event Description

A customer in (b)(6) alleged that on (b)(6) 2019 a 3dmax light left mesh was opened, "but inside the box it was not the left. " alleged the product was "poorly packed". More details have been requested, but no additional information is available at this time.

 
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Brand Name3DMAX LIGHT
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key8758011
MDR Text Key150135998
Report Number1213643-2019-05743
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 08/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0117311
Device LOT NumberHUCZ1661
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/16/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/23/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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