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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 MESH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH Back to Search Results
Catalog Number 5954450
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The sample has not been returned for evaluation, as such a definitive conclusion cannot be made. Events of this nature are typically associated to the user not hydrating the mesh as instructed in the instructions-for-use. However, without having the sample to evaluate no conclusion can be made. There is no indication from the investigation activities performed that would indicate a malfunction of the device occurred. To date this is the only reported complaint for this manufacturing lot of 288 units released for distribution in (b)(6) 2018. A review of the manufacturing records was performed and found that the lot was manufactured to specification not returned.
 
Event Description
It was reported that a bard ventralight st mesh was being used during a robotic assisted laparoscopic umbilical hernia repair. As reported the mesh was rolled and inserted down a 12mm trocar and while attempting to unroll the mesh in the abdominal cavity the st (hydrogel) coating peeled off. Another mesh was used to complete the case. There was no injury to the patient.
 
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Brand NameVENTRALIGHT ST MESH
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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key8132572
MDR Text Key129589383
Report Number1213643-2018-04396
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,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2020
Device Catalogue Number5954450
Device Lot NumberHUCT1428
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2018
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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