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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954680
Device Problem Expiration Date Error (2528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/06/2021
Event Type  malfunction  
Manufacturer Narrative
The user facility reported that they inadvertently implanted an expired ventralight 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. As reported, additional training has been provided to the or staff. Review of manufacturing records indicate product was manufactured to specification. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in january, 2020. Should additional information be provided, a supplemental mdr will be submitted. Not returned. Remains implanted.
 
Event Description
As reported, during a robotic assisted epigastric/ umbilical hernia repair procedure on (b)(6) 2021, the patient was implanted with a bard/davol ventralight st mesh which had expired on 28-sep-2020. As reported, the or staff did inspect the packaging and the mesh prior to implant, however, did not note the expiration date as beyond its labeled shelf life. The patient was followed closely and there have been no adverse effects. No additional medical/surgical intervention was required. Hospital contact stated that additional training has been provided to the or staff to mitigate future occurrences.
 
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Brand NameVENTRALIGHT ST MESH
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 Key11292614
MDR Text Key230707775
Report Number1213643-2021-20021
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 health professional,other,use
Reporter Occupation
Type of Report Initial
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2020
Device Catalogue Number5954680
Device Lot NumberHUCW0578
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 Received01/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/22/2020
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: 02/08/2021 Patient Sequence Number: 1
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