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

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.

• Brand Name: VASC BAND
• Type of Device: HEMOSTAT
• Manufacturer (Section D): LEPU MEDICAL TECHNOLOGY LTD.; 3rd floor, beikong science; 10 baifuquan road changping; beijing, 10220 0; CH 102200
• MDR Report Key: 6419143
• MDR Text Key: 70406828
• Report Number: 2134812-2017-00032
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• 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 Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3524
• Device Lot Number: 201609013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention