MAUDE Adverse Event Report: OLYLIFE INTERNATIONAL SDN BHD OLYLIFE TERA P90; MASSAGER, THERAPEUTIC, ELECTRIC

Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Unspecified Tissue Injury (4559)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Multiple patients seen with burns, wounds and injuries utilizing olylife tera p90.

• Brand Name: OLYLIFE TERA P90
• Common Device Name: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): OLYLIFE INTERNATIONAL SDN BHD
• MDR Report Key: 24832568
• Report Number: MW5186559
• Device Sequence Number: 5865145
• Product Code: ISA
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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?: No
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown