inforMED
OtherFSD

13982000 AB BNDR 12" UNIV 46-62

Received Apr 15, 2002 · Event occurred Mar 5, 2002

Report 1037420-2002-00001 · MDR key 389435

Device

Generic name

Dbg Debql Chest Products

Model number

NA

Catalog number

13982000

Lot number

NOT AVAILABLE

Product problems

  • Reaction
  • Replace

Patient

UNKNOWN

  • Blister(s)
  • Rash
  • Therapy/non-surgical treatment, additional
  • Treatment with medication(s)

Narrative

Description of Event or Problem

BINDER HAS CAUSED A RASH ON THE PATIENT'S SKIN IN ALL AREAS WHERE THE BINDER CONTACTED THE SKIN. BLISTERS DEVELOPED. THIS WAS PUT ON THE PATIENT FOLLOWING NEURO SURGERY. THE HOSPITAL THINKS THIS PRODUCT IS LABELED LATEX SAFE BUT THE BOX HAS BEEN DESTROYED AND THEREFORE THE LOT NUMBER AND LATEX INFORMATION IS NOT AVAILABLE. PATIENT WAS GIVEN HYDROCORTIZONE AND BENADRYL, THE BINDER WAS REMOVED AND A DIFFERENT BINDER PLACED ON THE PATIENT PRIOR TO DISCHARGE FROM THE HOSPITAL. THE BINDER USED ON THE PATIENT HAS BEEN RETURNED TO COMPANY.