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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX PORCINE SURGICAL MESH Back to Search Results
Catalog Number 1161015
Device Problem Shelf Life Exceeded (1567)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/06/2018
Event Type  malfunction  
Manufacturer Narrative
As reported by the facility the expired device was implanted in error. A review of our records show that the device was provided to the facility prior to the date of expiry (02/28/2018). This event is confirmed for use related. The instructions-for-use instructs the user to inspect the package prior to use. 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 an emergency case was performed on (b)(6) 2018. During this procedure a davol xenmatrix graft was placed. As reported following the procedure while processing the records it was identified that the labeled expiration date of the implanted device was 02/28/2018. Per materials manager, the unit was from the hospital inventory. The risk manager confirmed the use error on the part of the facility. The risk manager was informed that there was no test data to support a longer shelf life for the product. Hospital planned to inform the patient of the error that occurred. At this time there has been no patient complications or medical intervention.
 
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Brand NameXENMATRIX
Type of DevicePORCINE SURGICAL 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 Key7504361
MDR Text Key108361025
Report Number1213643-2018-01412
Device Sequence Number1
Product Code FTM
UDI-Device Identifier00801741031380
UDI-Public(01)00801741031380
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue Number1161015
Device Lot NumberHUAQ0052
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 Received05/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2016
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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