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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY LTD. VASC BAND HEMOSTAT

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LEPU MEDICAL TECHNOLOGY LTD. VASC BAND HEMOSTAT Back to Search Results
Model Number 3524
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemostasis (1895)
Event Date 02/21/2017
Event Type  Injury  
Manufacturer Narrative
Investigation report received by manufacturer. No anomaly in product was found, according to the complaint description and returned product inspection. This is not an issue caused by product defect. As there is no evidence of product malfunction. A review of the device history record of the involved product, confirmed there was not any anomaly in product manufacture and inspection process.
 
Event Description
The patient had some "oozing" after 2mls of air was removed from the balloon, the rn inserted the 2mls back into the balloon and noted the "oozing" stopped. She went back to check on the patient, and the balloon had went completely flat. She re-inflated with 6mls, ensured the patient was ok and when she went back to check again, the balloon was flat again. "" the vascband was removed and a new vascband was placed.
 
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Brand NameVASC BAND
Type of DeviceHEMOSTAT
Manufacturer (Section D)
LEPU MEDICAL TECHNOLOGY LTD.
3rd floor, beikong science
10 baifuquan road changping
beijing, 10220 0
CH 102200
MDR Report Key6419143
MDR Text Key70406828
Report Number2134812-2017-00032
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 02/23/2017,02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3524
Device Lot Number201609013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/22/2017
Event Location Hospital
Date Report to Manufacturer02/23/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/20/2017 Patient Sequence Number: 1
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