MAUDE Adverse Event Report: INFRARED &LYMPHATIC DRAINAGE BODY WRAP; LAMP, INFRARED, THERAPEUTIC HEATING

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Headache (1880); Numbness (2415)

Event Date 03/27/2021

Event Type  Injury  

Event Description

I bought a (b)(6) for a lymphatic body wrap at (b)(6) with esthetician (b)(6).After wrap was in place, i was left unattended for about 25 minutes unable to move and control the pressure of the wrap left with some bruising and numbing in my arms.With post tingling and headache.Esthetician said she would get the machine looked at and postpone appointments that day.Fda safety report id# (b)(4).

• Brand Name: INFRARED &LYMPHATIC DRAINAGE BODY WRAP
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• MDR Report Key: 11596296
• MDR Text Key: 243613151
• Report Number: MW5100440
• Device Sequence Number: 1
• Product Code: ILY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 59