inforMED
InjuryJCB

ENZOL ENZYMATIC DETERGENT

Received Feb 16, 2001 · Event occurred Jul 1, 2000

Report 2084725-2001-00011 · MDR key 316386

Device

Generic name

Enzymatic Detergent

Model number

NA

Catalog number

2252

Lot number

L100201

Product problems

  • Reaction

Patient

40 YR

  • Allergic reaction
  • Hypersensitivity/Allergic reaction
  • Itching Sensation
  • Rash
  • Other (for use when an appropriate patient code cannot be identified)
  • Wheal(s)
  • Therapy/non-surgical treatment, additional
  • Treatment with medication(s)

Narrative

Description of Event or Problem

INSTRUMENT TECH USING ENZOL DETERGENT SINCE 1999 PURPORTEDLY BEGAN HAVING A REACTION TO THE PRODUCT APPROXIMATELY SIX MONTHS AGO. BEGINNING WITH A RASH ON THE BACK OF THE LEFT HAND, TURNING INTO ITCHY WELTS. AFTER DIAGNOSIS OF LATEX ALLERGY, THE TECHNICIAN SWITCHED FROM USING LATEX GLOVES TO NITRILE GLOVES WITH NO RELIEF. AFTER THE WELTS SPREAD TO THE TECHNICIAN'S FEET, CHEST AND BACK, THE TECHNICIAN VISITED THE TECHNICIAN'S FAMILY PHYSICIAN. THE PHYSICIAN THOUGHT IT MIGHT BE A REACTION OR ALLERGY TO PENICILLEN PRESCRIBED. LAB WORK WAS PERFORMED TO CONFIRM THE ALLERGY TO LATEX. THE TEST CAME BACK NEGATIVE. WHEN THE TECHNICIAN RETURNED TO WORK, THE TECHNICIAN WAS SENT TO THE ER THE SAME DAY WITH A RASH. THE TECHNICIAN'S FAMILY PHYSICIAN PRESCRIBED A PREDNISONE DOSEPAK WHICH GAVE THE TECHNICIAN'S IMMEDIATE RELIEF. THE TECHNICIAN'S DR PRESCRIBED MORE PREDNISONE ALONG WITH ALLEGRA AND TAGAMET (600 MG) TWICE PER DAY. WHEN THE TECHNICIAN'S SYMPTOMS RETURNED, THE TECHNICIAN WAS REFERRED TO A DERMATOLOGIST. THE DERMATOLOGIST PRESCRIBED ULTRAVATE CREAM WITH VITAMIN D3 AND DISCONTINUED THE ORAL MEDICATIONS. THE TECHNICIAN'S SYMPTOMS WORSENED OVER THE 2 WEEK COURSE OF TOPICAL MEDICATION. THE TECHNICIAN WAS THEN REFERRED TO AN ALLERGIST WHO TOOK SKIN SAMPLES WHICH CAME BACK WITH A NEGATIVE RESULT. THE ALLERGIST FELT THAT THE PENICILLIN COULD HAVE CAUSED HYPERSENSITIVITY WHEN USING THE ENZOL DETERGENT. THE ALLERGIST PRESCRIBED ZYRTEC, WHICH SEEMED TO WORK BUT MADE THE TECHNICIAN DROWSY. THE TECHNICIAN THEN PRESCRIBED SINGULAIR WHICH HAS APPEARED TO HELP THE SYMPTOMS SOMEWHAT. THE TECHNICIAN IS NOW TAKING SINGULAIR, ALLEGRA AND TAGAMET TWICE PER DAY. THEY HAVE CHANGED TO ENDOZYME AW+ UNSCENTED.