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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALEX ST SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALEX ST SURGICAL MESH Back to Search Results
Catalog Number 5950009
Device Problem Expiration Date Error (2528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Manufacturer Narrative
The user facility reported that they inadvertently implanted an expired ventralex st mesh into the patient. The expiration date is located on multiple layers of the packaging. This event is confirmed as a use related error with no malfunction of the device. No patient injury was reported. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in may, 2019. Should additional information be provided, a supplemental mdr will be submitted.
 
Event Description
As reported during an open umbilical hernia repair procedure on (b)(6) 2021, the surgeon implanted a bard/davol ventralex st which had expired on 28-mar-2021 in the patient. It was reported that there were no medical or surgical intervention. There was no reported patient injury.
 
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Brand NameVENTRALEX ST
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
8005566756
MDR Report Key11725452
MDR Text Key247350744
Report Number1213643-2021-20095
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2021
Device Catalogue Number5950009
Device Lot NumberHUDR0717
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/26/2021 Patient Sequence Number: 1
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