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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 5954810
Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Information (3190)
Event Date 10/12/2020
Event Type  Injury  
Manufacturer Narrative
As reported, the implanted ventralight st mesh tore from the surgical site. It is unclear at this time what symptoms the patient experience and what treatment was provided. The information provided is limited to the maude event report. Contact information was not provided, as such we are unable to request additional information. Based on the information available at this time, no conclusions can be made. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february, 2018. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be provided, a supplemental mdr will be submitted. Not returned.
 
Event Description
The following was reported via maude event report (mw5097358) alleging adverse outcomes against ventralight st: "implanted ventralight st mesh tore from original surgical site. ".
 
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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 Key10842638
MDR Text Key216317846
Report Number1213643-2020-20045
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031687
UDI-Public(01)00801741031687
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 Non-Healthcare Professional
Type of Report Initial
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/28/2020
Device Catalogue Number5954810
Device Lot NumberHUCN0230
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2018
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: 11/16/2020 Patient Sequence Number: 1
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