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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problems Material Separation (1562); Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2016
Event Type  malfunction  
Manufacturer Narrative
The sample was returned for evaluation and is confirmed for material separation of the st coating. As reported the user hydrated the device well beyond the recommended time (1-3 seconds). The product instructions for use, which is supplied with the device states,"hydrate the mesh for no more than 1-3 seconds just prior to rolling. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. Based on the sample evaluation and the event as reported, root cause is determined to be a use related event as the user hydrated the mesh for a much longer period of time than is recommended. 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.
 
Event Description
It is reported that during a robotic ventral hernia repair procedure a ventralight st w/ echo ps implant was used to treat the patient. The implant was reported to have been allowed to hydrate for 20 minutes and was then placed onto the introducer tool and placed in the body. The surgeon noted that the sepra-technology (st) coating was coming free from the mesh and the implant was removed. Another ventralight st w/ echo ps was used to complete the case. There was no patient injury. Had the device been implanted the lack of coating could compromise the performance of the device impacting the patient outcome. As such an mdr was reported to document this event.
 
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Brand NameVENTRALIGHT ST W/ECHO
Type of DeviceSURGICAL 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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6125958
MDR Text Key60868638
Report Number1213643-2016-00539
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2018
Device Catalogue Number5955600
Device Lot NumberHUAU0243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received11/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2016
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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