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 Problem Hematoma (1884)

Event Date 05/24/2019

Event Type  Injury  

Manufacturer Narrative

Tracked the production and inspection record of lot 201809008 and found no abnormal.Examined 3 remained production samples of lot 201809008 and found the samples were all qualified.The product instruction also explained that hematoma is a potential adverse event.Inspected the returned products and fount the inflation and deflation was normal.Could not have sufficient application information, no product abnormal was found via inspecting the returned products.There was no evidence that could prove product failure.Continuous attention will be paid to this issue in the future.

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 mfr report # 3008002401-2019-00002.

• Brand Name: VASC BAND
• Type of Device: HEMOSTAT
• 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 Key: 8738378
• MDR Text Key: 149328775
• Report Number: 3008002401-2019-00001
• 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: 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 Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3524
• Device Lot Number: 201809008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 74 YR
• Patient Weight: 74