inforMED
InjuryIPS

CAREX

Received Dec 31, 2018 · Event occurred Aug 27, 2018

Report 3012316249-2018-00067 · MDR key 8206266

Device

Generic name

Cane

Model number

FGA74100 0000

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Laceration(s)
  • Laceration(s)

Narrative

Description of Event or Problem

UPDATE TO EVENT INFORMATION IDENTIFIED ON (B)(6) 2019: BASED ON IDENTIFYING FEATURES IN THE PHOTOS PROVIDED, THE CANE INVOLVED WITH THIS EVENT HAS BEEN IDENTIFIED AS LIKELY BEING THE FGA74100 0000 CAREX OFFSET DESIGNER QUAD CANE. LOT# INFORMATION REMAINS UNAVAILABLE AT THIS TIME. SUPPLIER OF CANE HAS BEEN UPDATED TO AID-PRO HEALTHCARE, OR NOW COM-DA.

Description of Event or Problem

THE END-USER SUSTAINED SEVERE & DISFIGURING PERSONAL INJURIES WHEN THE BASE OF A QUAD CANE LACERATED HER LEG. INFORMATION REGARDING THE MODEL NUMBER OF THE QUAD CANE HAS NOT BEEN REPORTED.