inforMED
InjuryISH

RENEGADE PROSTHETIC FEET

Received Jan 24, 2020 · Event occurred Dec 24, 2019

Report MW5092531 · MDR key 9632460

Device

Generic name

Component, External Limb, Ankle/ Foot

Manufacturer

Unk

Product problems

  • Product Quality Problem

Patient

25 YR

  • Hemorrhage/Blood Loss/Bleeding
  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

EXTENDED BLEEDING TIME. (B)(6) FRAUD RESULTING IN GROSS BODILY HARM; THERAPY START DATE: (B)(6) 2016, END DATE: (B)(6) 2020. SUBSTANDARD PROSTHETIC DEVICES FRAUD WASTE AND ABUSE. FDA SAFETY REPORT ID# (B)(4).