MAUDE Adverse Event Report: VALD PERFORMANCE AIRBANDS WIRELESS BFR CUFFS; TOURNIQUET, PNEUMATIC

Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	01/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
I recently received airbands wireless bfr cuffs for christmas.I followed the instructions on the app but the cuffs inflated way too much on my arm and wouldn't release the air.I couldn't get the bfr cuff removed myself and my arm turned purple.Eventually i was able to get it off with help but now the app won't even connect with the cuff.I reached out to the company, but they apparently are based in australia and didn't respond.I feel many other athletes may be put in this situation and feel the fda should step in and make sure these are safe.Fda safety report id # (b)(4).

• Brand Name: AIRBANDS WIRELESS BFR CUFFS
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): VALD PERFORMANCE; 115 breakfast creek rd.newstead; queensland ; AS
• MDR Report Key: 11163353
• Report Number: MW5098793
• Device Sequence Number: 2833939
• Product Code: KCY
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention