inforMED
MalfunctionFYF

BOUFFANT CAP, ANNIE BLUE LARGE

Received Dec 17, 2021 · Event occurred Nov 19, 2021

Report 3004763499-2021-00002 · MDR key 13028252

Device

Generic name

Surgical Cap, Single-use

Model number

621815

Lot number

21276594

Product problems

  • Nonstandard Device
  • Nonstandard Device

Patient

Female

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

Narrative

Description of Event or Problem

A PATIENT FOUND A BROKEN SEWING MACHINE NEEDLE IN HER HAIR WHEN REMOVING THE CAP AFTER AN MRI.