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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRIO MESH SURGICAL MESH Back to Search Results
Catalog Number 0010213
Device Problems Shelf Life Exceeded (1567); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
This event is confirmed as a use related error. The labeled expiration date on the product is 03/28/2018 and as reported was implanted on (b)(6) 2018. The product was provided to the facility on 06/17/2015, approximately three years prior to implant. Multiple good faith efforts were made requesting additional information. This included asking whether any additional medical or surgical intervention was administered due to this error. To date there has been no response. A review of the manufacturing records shows that the product expiration date ¿03/2018¿ on all printed labels is the correct in accordance to the procedure and all other applicable manufacturing procedures. Should additional information be provided, a supplemental emdr will be submitted. 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; not returned.
 
Event Description
The user facility reported that on (b)(6) 2018 an expired ventrio mesh was inadvertently placed in a patient. The labeled expiration date is 03/28/2018.
 
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Brand NameVENTRIO MESH
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 Key7635647
MDR Text Key112562115
Report Number1213643-2018-02180
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741016400
UDI-Public(01)00801741016400
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100229
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 06/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2018
Device Catalogue Number0010213
Device Lot NumberHUZC0582
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2015
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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