inforMED

COLLODION 11

Received Jun 8, 2012 · Event occurred May 31, 2012

Report 2613797 · MDR key 2613797

Device

Generic name

Collodion 11, Ether Free

Manufacturer

Mavidon

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Patient-Device Incompatibility

Patient

51 YR

  • Dyspnea
  • Erythema
  • Hypersensitivity/Allergic reaction
  • Itching Sensation
  • Rash
  • Swelling
  • Tachycardia
  • Hot Flashes/Flushes
  • Dizziness
  • Urticaria
  • Sweating

Narrative

Description of Event or Problem

A PATIENT HAD A 24-HOUR EEG LEADS PLACED USING COLLODION AND WAS SENT HOME. THE PATIENT BEGAN TO FEEL VERY HOT, SWEATING, ITCHING AND WITH RED COLOR SPOTS ON HER HEAD. SHE WAS SEND TO THE ED (EMERGENCY DEPARTMENT). IN THE ED, THE PATIENT WAS NOTED HAVING AN ALLERGIC REACTION WITH SHORTNESS OF BREATH, THROAT SWELLING, HIVES, DIZZINESS, TACHYCARDIA, AND EXPIRATORY WHEEZES. OXYGEN WAS APPLIED; ALBUTEROL VIA NEBULIZER AND EPINEPHRINE SUBCUTANEOUS WAS ADMINISTERED. THE PATIENT'S HEAD WAS SHAVED TO REMOVE ALL TRACES OF GLUE BELIEVED TO BE CAUSING THE REACTION. PATIENT WAS STABILIZED AND DISCHARGED HOME.