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

Model Number 3524

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 08/30/2023

Event Type  Injury  

Event Description

It was reported that: customer states "vac band leaking air.Issues with rebleeding, hematoma and vascular surgery.".

Manufacturer Narrative

Email to inquiry questions: 1) can you confirm the batch information? 2) may i ask where the leak is located? how long did it take to detect air leakage? how to detect air leakage? is there a retest for air leakage? 3) can you provide a detailed usage process, including the initial inflation amount and how long will it take to deflate? what is the amount of air released? and what device is used for venting and recycling information? 4) what accidents did this product cause? can you provide a detailed explanation? what medical interventions did the doctor provide to the patient in the future? what is the final result? 5) can the product be returned for cause analysis? agent response: no more valid information was obtained from the hospital.Due to the inability to determine the batch number, dhr and production inspection records cannot be investigated at the moment.The production and inspection process of our company's products strictly follows the operation instructions.The relaxation of the product's airbag needs to undergo a full production inspection, and the strength of the airbag needs to undergo quality sampling.The production process quality of the product is stable and reliable.Due to the failure to obtain more effective information on medical personnel's inflation and deflation operations, and the failure to receive the products involved in the complaint, it is not possible to analyze and determine the specific situation of air leakage.Therefore, it is impossible to determine the exact cause of this adverse event.It is recommended to use hospitals to accurately record the specific inflation and deflation amounts of abnormal products, as well as effective information such as the time when air leaks are found, and to help confirm the location of air leaks.

• Brand Name: VASC BAND
• Type of Device: HEMOSTAT
• Manufacturer (Section D): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD; no.37 chaoqian rd.; changping district; beijing, 10220 0; CH 102200
• Manufacturer (Section G): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD; no.37 chaoqian rd.; changping district; beijing, 10220 0; CH 102200
• Manufacturer Contact: bo jiang ; no.37 chaoqian rd.; changping district; beijing, 10220-0 ; CH 102200
• MDR Report Key: 18145980
• MDR Text Key: 328225454
• Report Number: 3008002401-2023-00008
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3524
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention