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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 Problem Injury (2348)
Event Date 10/22/2019
Event Type  Injury  
Manufacturer Narrative

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 instructs the user to, "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. " 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. Discarded.

 
Event Description

As reported on (b)(6) 2019 a ventralight st w/ echo ps device was used during a surgical procedure. As reported the surgeon completed and closed the patient and did not realize until the patient was in the recovery that he had forgotten to remove the positioning system from the patient. The patient was brought back to the operating room where the surgeon successfully removed the positioning system via a laparoscopic procedure. As reported, there was no injury to the patient and the patient has been discharged from the hospital.

 
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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 Key9289509
MDR Text Key165418411
Report Number1213643-2019-10731
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 11/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2020
Device Catalogue Number5955460
Device LOT NumberHUCY1824
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/26/2019
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: 11/07/2019 Patient Sequence Number: 1
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