MAUDE Adverse Event Report: SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC. DBA AS SOFTWAVE TRT SOFTWAVETRT; MASSAGER, THERAPEUTIC, ELECTRIC

Patient Problems Tinnitus (2103); Increased Sensitivity (4538)

Event Date 11/27/2023

Event Type  Injury  

Event Description

Softwavetrt: signed up for a consultation/sample for softwavetrt treatment on my back/shoulder blade are and was offered a package for multiple treatments.The technician did a little on my shoulder blade but focused on my shoulder and left trapezius.My 2nd treatment on (b)(6) 2023 resulted in a vibration in my ears that went away after a day.My 3rd treatment left me with ringing in both ears, more on the left.The technician said the ringing could not be caused by the softwave, but after a 4th treatment, i had ringing, pressure, and pain in my ears.I still have the ringing in both ears and increased volume as of (b)(6) 2024.I also have times of noise sensitivity.

• Brand Name: SOFTWAVETRT
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): SOFTWAVE TISSUE REGENERATON TECHNOLOGIES, LLC. DBA AS SOFTWAVE TRT
• MDR Report Key: 18660861
• MDR Text Key: 334897361
• Report Number: MW5151136
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• 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: 02/03/2024

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2024