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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 5955790
Device Problem Use of Device Problem (1670)
Patient Problems Injury (2348); Foreign Body In Patient (2687)
Event Date 09/20/2018
Event Type  Injury  
Manufacturer Narrative
Based on the events as reported, the echo ps positioning system was not removed from the patient as prescribed in the instructions-for-use. This complaint is confirmed as use related with no malfunction of the device. The warning section of the instructions-for-use states: "the echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant. " the instructions-for-use also prescribes the proper method for use 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
As reported, on (b)(6) 2018 the patient underwent a laparoscopic ventral hernia repair with implant of the ventralight st mesh. This mesh was a part of the echo ps inflation assembly. The case was completed and the patient was sent to recovery. The surgeon was performing his second case of the day, using another mesh with the echo ps device when he realized he had not removed the echo ps from the previous patient. That afternoon, the surgeon brought the patient back to the or to remove the echo ps inflation balloon. The mesh itself was fine and remained implanted. The patient is reported to be recovering without any adverse effects.
 
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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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7960101
MDR Text Key123510404
Report Number1213643-2018-03511
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741031762
UDI-Public(01)00801741031762
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122436
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 10/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2020
Device Catalogue Number5955790
Device Lot NumberHUCP2448
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 Received09/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2018
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: 10/12/2018 Patient Sequence Number: 1
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