inforMED
InjuryIPR

DRIVE

Received Aug 29, 2017 · Event occurred Aug 1, 2017

Report 2438477-2017-00071 · MDR key 6826647

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Product code (IPR)
Model (10403)

Device

Generic name

Crutch

Model number

10403

Product problems

  • Break

Patient

33 YR

  • No Code Available
  • No Code Available

Narrative

Description of Event or Problem

(B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A CRUTCH. FOREARM CRUTCH ALLEGEDLY BROKE AT THE 5TH HOLE FROM THE BOTTOM DURING USE. END-USER REOPENED INCISION ON RECENTLY AMPUTATED LEFT LEG.