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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST SURGICAL MESH Back to Search Results
Catalog Number 5954460
Device Problems Shelf Life Exceeded (1567); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2017
Event Type  malfunction  
Manufacturer Narrative
As reported the expired device was implanted in error. 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. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Remains implanted.
 
Event Description
It was reported that on (b)(6) 2017 a ventralight st mesh with an expiration date of (b)(6)2017 was inadvertently implanted into the patient. To date there has been no reported intervention or injury to the patient.
 
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Brand NameVENTRALIGHT ST
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 Key7179689
MDR Text Key96891280
Report Number1213643-2018-00040
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Catalogue Number5954460
Device Lot NumberHUZA1661
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 Received12/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2015
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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