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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 Material Perforation (2205)
Patient Problem Hernia (2240)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
About 3 months post-implant of the bard/davol ventralight st mesh, the patient reported a "hole in the mesh" and an ultrasound test indicated a possible hernia recurrence. However, based on the subsequent ct-scan performed and patient visit, the surgeon confirmed that no hernia recurrence was observed. As reported the mesh remains implants with no further intervention currently scheduled. Based on the information provided the possible cause of the patient¿s reported outcome of a ¿lump and swelling at the hernia repair site¿ is unclear and the condition of the mesh does not appear to be of concern to the surgeon. In addition, while it has been reported no hernia recurrence has occurred, hernia recurrence is a known inherent risk of hernia repair surgery. 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 207 units released for distribution in (b)(6) 2020. Note, the date of event is estimated based on the date of the initial ultrasound test performed. Should additional information be provided, a supplemental mdr will be submitted.
 
Event Description
As reported, the patient underwent unspecified surgery on (b)(6) 2020 for implant of a bard/davol ventralight st which was fixated using a bard/davol capsure straight fixation device and the mesh had a ¿hole¿ in it and more than likely ¿defected¿. As reported, recurrence hernia may have occurred from the hole in the mesh after implantation. As reported, based on a history of ¿lump and swelling at the hernia repair site¿, the patient underwent an ultrasound on (b)(6) 2020. The finding of this ultrasound indicated what ¿appears to be a defect in the hernia mesh with what appears to be fat extending through¿ with a final impression being stated as a "periumbilical hernia in the area of previous repair". However, a subsequent ct scan was performed which is reported to have confirmed there is no hernia recurrence in the area of the mesh. As reported, in addition, the surgeon has seen the patient and has confirmed there was no hernia recurrence. It is being reported, that no further intervention is currently being scheduled.
 
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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 Key11716188
MDR Text Key247281279
Report Number1213643-2021-20090
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5954680
Device Lot NumberHUES1059
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 Received03/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2020
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: 04/23/2021 Patient Sequence Number: 1
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