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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 3529
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Hematoma (1884)
Event Date 05/24/2019
Event Type  Injury  
Event Description
There were two vasc bands used post procedure, the first band was applied to the distal right radial site. Patient noted with a severe hematoma. The second band was placed after swelling above the first band. Compartment syndrome was reported and subsequent surgical intervention was reported. This report is also associated to uf/importer report # 2134812-2019-00045.
 
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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 Key8727674
MDR Text Key148974235
Report Number2134812-2019-00046
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 Physician Assistant
Type of Report Initial
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3529
Device Lot Number201811002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/28/2019
Event Location Hospital
Date Report to Manufacturer05/28/2019
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/24/2019 Patient Sequence Number: 1
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