inforMED
InjuryNTO

GUM PERIO SHIELD

Received Aug 26, 2021 · Event occurred Jan 1, 2021

Report MW5103524 · MDR key 12377136

Device

Generic name

Rinse, Oral, Antibacterial (by Physical Means)

Lot number

"02A,02A,01A,02Z"

Product problems

  • Contamination

Patient

71 YR

  • Unspecified Infection
  • Skin Disorders
  • Unspecified Infection
  • Skin Disorders

Narrative

Description of Event or Problem

THE (B)(4) - GUM - 1775R PERIOSHIELD ORAL HEALTH RINSE, 10 OUNCE BOTTLE USED THIS CONTAMINATED PRODUCT IN CONJUNCTION WITH A FACE MASK AND CAUSED INFECTIONS ON THE SKIN. REPORTED TO THE MANUFACTURER - REFERRED TO MANUFACTURER 6/28/2021 SAID WOULD RESPOND, NO RESPONSE.