inforMED
MalfunctionIRT

SHARK FACIALPRO¿ GLOW

Received May 7, 2026 · Event occurred Mar 23, 2026

Report 3013738756-2026-00025 · MDR key 25112194

Device

Generic name

"pack, Hot Or Cold, Reusable

Model number

FH220UKBK

Product problems

  • Insufficient Device Problem Information

Patient

NA · Unknown

  • Electric Shock

Narrative

Additional Manufacturer Narrative

THE EVENT WAS NOT REPORTED WITHIN THE REQUIRED REPORTING TIMEFRAME DUE TO DELAYED INTERNAL ESCALATION. UPON IDENTIFICATION, THE COMPLAINT WAS IMMEDIATELY EVALUATED FOR REPORTABILITY AND SUBMITTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION OCCURS.

Description of Event or Problem

THE CUSTOMER REPORTED AFTER THE DEVICE SHOCKED THEM AND EMITTED BURNING SMELL. THE CUSTOMER STOPPED USING DEVICE.