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

Model Number	REJ6
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted customer service via email and reported that while charging the base unit (battery pack), it caught fire.The customer was not using the device when the event occured.There were no injuries, and no medical intervention was required.

• Brand Name: HYPERICE / NORMATEC
• Common Device Name: POWERED INFLATABLE TUBE MASSAGER
• Manufacturer (Section D): NORMATEC INDUSTRIES, LP; 480 pleasant street; watertown MA 02472
• Manufacturer Contact: jon howell ; 480 pleasant street; watertown, MA 02472 ; 7142928954
• MDR Report Key: 22609504
• Report Number: 3003619590-2025-00002
• Device Sequence Number: 13152670
• Product Code: IRP
• UDI-Device Identifier: 00810050281997
• UDI-Public: 00810050281997
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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
• Device Model Number: REJ6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 21 YR
• Patient Sex: Male