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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 Problem Torn Material (3024)
Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422)
Event Date 10/28/2016
Event Type  Injury  
Manufacturer Narrative
The sample was not returned to davol for evaluation. As reported during the implant procedure the balloon assembly was removed through a trocar and it was not noticed that the balloon had torn. Regarding removal of the echo ps positioning system the instructions for use (ifu) state, "begin removal of the echo ps positioning system by grasping one of the two removal points marked by the dark arrows adjacent to the bard logo. Begin pulling the positioning system off the mesh in one smooth motion. Continue removing the echo ps positioning system, pulling it up to the tip of the trocar. Remove both the echo ps positioning system and trocar simultaneously. Verify that the echo ps positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact, discard the echo ps positioning system appropriately. Based on the events as reported the user did not identify the damage to the balloon assembly, which likely presented during attempted removal. A review of the manufacturing records was performed and found that the lot was manufactured to specification. 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
The following was reported to davol: on (b)(6) 2016 - the patient underwent the laparoscopic repair of an incisional hernia with a ventralight st w/ echo ps. On (b)(6) 2016 - the patient underwent an additional procedure due to an obstruction. During this procedure it was noted that a small piece of the balloon material (echo ps) was fused with tissues and was removed. As reported during the implant procedure the balloon was removed through a trocar and it was not noticed that the balloon had torn and a piece was left in the body. The patient is reported to have recovered.
 
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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 Key6124092
MDR Text Key60760168
Report Number1213643-2016-00538
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 foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 11/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Catalogue Number5955600
Device Lot NumberHUAP1415
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2016
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: 11/23/2016 Patient Sequence Number: 1
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