inforMED
MalfunctionEFS

WATER PIK CORDLESS ADVANCED WATER FLOSSER

Received Aug 25, 2023 · Event occurred Aug 10, 2023

Report 0001712259-2023-00014 · MDR key 17627183

Device

Generic name

Oral Irrigator

Manufacturer

Water Pik Inc.

Model number

WP-563

Lot number

170227HAP

Product problems

  • Burst Container or Vessel
  • Burst Container or Vessel

Patient

Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CUSTOMER CHATTED IN ON 8/10 REGARDING INCIDENT THAT TOOK PLACE A MONTH PRIOR. CUSTOMER ALLEGES THAT THE UNIT "EXPLODED" DURING USE. SAYS A PIECE BROKE OFF AND HIT HIS LIP. NO DAMAGE TO PERSON OR PROPERTY (OTHER THAN THE FLOSSER). DID NOT SEEK MEDICAL OR PROFESSIONAL ATTENTION. SEEKING EITHER REPLACEMENT OR REFUND.

Remedial action

  • Replace