DERMALINFUSION SPP SYSTEM
Received Feb 12, 2025 · Event occurred Jan 17, 2025
Report 3007215625-2025-00100 · MDR key 21367833
Device
Generic name
Brush/dermabrasion/powered
Manufacturer
Allergan PleasantonProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
THE DIAMOND GLOW USER MANUAL STATES, "TYPICAL SIDE EFFECTS INCLUDE A SCRATCHY, STINGING SENSATION DURING THE TREATMENT AND TEMPORARY TIGHTNESS, REDNESS OR SLIGHT SWELLING AFTER THE TREATMENT. SERIOUS SIDE EFFECTS ARE UNCOMMON AND UNLIKELY. HOWEVER, SHOULD YOUR PATIENT NOTICE ANY OF THE FOLLOWING SIDE EFFECTS, CEASE USE IMMEDIATELY.¿
Description of Event or Problem
ALLERGAN AESTHETICS RECEIVED A REPORT THAT A PATIENT RECEIVED A DIAMOND GLOW TREATMENT TO THE FACE USING THE HA5 HYDRA COLLAGEN DIAMOND GLOW SERUM, 120 DIAMOND TIP AND PRESENTED WITH INFLAMED RED STROKE MARKS APPEARING ON LEFT SIDE OF NECK AND A STRIP UNDER THE RIGHT EYE. PATIENT WAS INSTRUCTED TO TAKE ANTIHISTAMINE. AFFECTED AREAS WERE CALM AFTER AN HOUR.