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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD VASC BAND CLAMP, VASCULAR

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LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD VASC BAND CLAMP, VASCULAR 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
No anomaly in product was found, according to the complaint description and returned product inspection. This is not an issue cause by product quality defect.
 
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 DeviceCLAMP, VASCULAR
Manufacturer (Section D)
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
no.37, chaoqian road
changping district
beijing, 10220 0
CH 102200
Manufacturer (Section G)
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
no.37, chaoqian road
changping district
beijing, 10220 0
CH 102200
Manufacturer Contact
bo jiang
no.37, chaoqian road
changping district
beijing, 10220-0
CH   102200
MDR Report Key8003259
MDR Text Key124956237
Report Number3008002401-2017-00003
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 03/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/21/2018
Device Model Number3524
Device Catalogue NumberN.A.
Device Lot Number201609013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/24/2018 Patient Sequence Number: 1
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