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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 Shelf Life Exceeded (1567); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
As reported the expired device was implanted in error. Our review shows that the lot was distributed prior to the expiration date. The product is packaged with the expiration clearly displayed on each level of packaging. The ifu instructs the user to inspect the package prior to use. This event is confirmed to be solely a use related error. Remains implanted.
 
Event Description
It was reported that on (b)(6) 2017 a 3dmax light mesh with an expiration date of 11/28/2017 was inadvertently implanted into the patient. To date there has been no reported intervention or injury to the patient. The contact was informed that if the packaging was not opened or damaged prior to implant the mesh would be anticipated to be sterile.
 
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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 Key7165252
MDR Text Key96638757
Report Number1213643-2018-00016
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,user f
Reporter Occupation
Type of Report Initial
Report Date 01/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2017
Device Catalogue Number0117311
Device Lot NumberHUWJ2080
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2012
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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