MAUDE Adverse Event Report: NORMATEC INDUSTRIES, LP HYPERICE / NORMATEC; POWERED INFLATABLE TUBE MASSAGER

Model Number	MODEL REJ6
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Hyperice was notified about a fire at a physical therapy clinic by the clinic's insurance carrier.The device is being evaluated among multiple potential causes for the fire.Hyperice has requested additional information from the clinic and its insurer in order to investigate whether a malfunction occurred, but it does not have more detail at this time.
Additional Manufacturer Narrative
The device was manufactured by a contract manufacturer, ryder electronics (xinfeng) ltd., located at east shuidong avenue, industrial park, xinfeng town, ganzhou city jiangxi, cn 341600.While awaiting set-up of its electronic submissions gateway, hyperice attempted to submit this report via email to mdrpolicy@fda.Hhs.Gov on december 26, 2024.

• Brand Name: HYPERICE / NORMATEC
• Common Device Name: POWERED INFLATABLE TUBE MASSAGER
• Manufacturer (Section D): NORMATEC INDUSTRIES, LP; 480 pleasant street,; suite a200; watertown MA 02472
• Manufacturer (Section G): RYDER ELECTRONICS (XINFENG) LTD.; east shuidong avenue; industrial park, xinfeng town; ganzhou city, jiangxi 34160 0; CH 341600
• Manufacturer Contact: jon howell ; 480 pleasant street; suite a200; watertown, MA 02472 ; 7142928954
• MDR Report Key: 21078642
• Report Number: 3003619590-2024-00002
• Device Sequence Number: 12453869
• Product Code: IRP
• UDI-Device Identifier: 00810050281997
• UDI-Public: 00810050281997
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K220217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2024

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: Health Professional
• Device Model Number: MODEL REJ6
• Device Lot Number: BATTERY LOT # 20211124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown