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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 5955460
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problems Anxiety (2328); Injury (2348)
Event Date 09/11/2019
Event Type  Injury  
Manufacturer Narrative

The echo ps positioning system which is intended to be removed from the abdomen, was not removed from the patient during the procedure as prescribed in the instructions-for-use. This complaint is confirmed as a use related event with no malfunction of the device. The warning section of the instructions-for-use states: "ventralight st mesh is the only permanent implant component of the device. 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 instructs the user to, "verify that the echo ps¿ positioning system including the balloon, all mesh connectors, and the inflation tube is fully intact after removal. " once the positioning system is verified to be fully intact discard the echo ps¿ positioning system appropriately. " not returned.

 
Event Description

The following was reported via maude event report mw5091719: "during the repair of umbilical hernia, ((b)(6) 2019) the echo ps positioning system ventralight mesh was used. The patient went home and was called back the next day as the surgeon suspected it was not removed. This balloon is not detectable on any imaging including x-ray, ct, or mri. An exploratory surgery needed to be performed ((b)(6) 2019). The balloon portion was left inside the patient. If there was an imaging marker on, the patient would have been taken imaging and not directly to surgery. " in follow up with customer contact it is reported that the surgeon is an experienced user of the device and the patient has recuperated, however has anxiety.

 
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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 Key9578292
MDR Text Key188794881
Report Number1213643-2020-00245
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER,USER FACILITY
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2021
Device Catalogue Number5955460
Device LOT NumberHUCZ0789
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 Received01/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/09/2019
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: 01/10/2020 Patient Sequence Number: 1
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