inforMED
InjuryONF

VENUS VIVA

Received Apr 24, 2024 · Event occurred Mar 25, 2024

Report 3006515340-2024-00003 · MDR key 19170672

Device

Generic name

Viva

Manufacturer

Venus Concept Ltd

Catalog number

VI102402GLB

Product problems

  • Inadequate Instructions for Non-Healthcare Professional
  • Inadequate Instructions for Non-Healthcare Professional

Patient

56 YR · Female

  • Skin Inflammation/ Irritation
  • Skin Inflammation/ Irritation

Narrative

Additional Manufacturer Narrative

SEE ATTACHED REPORT (B)(4).

Description of Event or Problem

(B)(6) EMAILED IN (B)(6) ON STAFF MEMBER WHICH DEVELOPED SEVERE SKIN REACTION WITH INQUIRED HOSPITAL ATTENTION.