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	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted the sales representative that then put the customer through to customer service and reported that while charging the base unit (battery pack), it sparked and caught fire.The customer was not using the device when the event occurred.There were no injuries, and no medical intervention was required.The reported damage was to the battery pack, which houses a lithium-ion battery supplied by (b)(4), a third-party supplier that hyperice no longer uses for batteries.No damage to the device itself was reported.
Additional Manufacturer Narrative
The device was manufactured by a contract manufacturer, ryder electronics (b)(6) ltd., located at (b)(6).While awaiting set-up of its electronic submissions gateway, hyperice attempted to submit this report via email to (b)(6) on (b)(6) 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: 21078628
• Report Number: 3003619590-2024-00004
• Device Sequence Number: 6832227
• Product Code: IRP
• UDI-Device Identifier: 00810050281997
• UDI-Public: 00810050281997
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 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: Lay User/Patient
• Device Model Number: MODEL REJ6
• Device Lot Number: BATTERY LOT # 20211213
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2022
• 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: Female