inforMED
MalfunctionFMQ

PROCARE WRAPAROUND LIMB HOLDER

Received Sep 16, 2024 · Event occurred Jul 4, 2024

Report 20224460 · MDR key 20224460

Device

Generic name

Restraint, Protective

Manufacturer

Djo, Llc

Model number

79-91430

Catalog number

79-91430

Lot number

TJ03848240521

Patient

2 MO · Male

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

Narrative

Description of Event or Problem

PATIENT WAS ORDERED TO HAVE SOFT WRIST RESTRAINTS APPLIED DUE TO AGITATION, COMBATIVENESS, AND ATTEMPTS TO REMOVE PERIPHERAL IV. RESTRAINTS PLACED AND SECUREMENT CHECKED BY RN. PCT ENTERED ROOM MINUTES LATER TO FIND LEFT WRIST RESTRAINT NO LONGER INTACT, THE WRIST PORTION WAS DETACHED FROM THE PIECE THAT SECURES TO THE BED. NEW SOFT WRIST RESTRAINT APPLIED AND THERE WAS NO PATIENT HARM.