FDA Adverse Event Injury Summary report: N

NEUTRALON SURGEON'S GLOVE

MDR report key: 21937 · Received May 22, 1995

Report

Report Number
MW1006039
Event Type
Injury
Date Received
May 22, 1995
Date of Event
June 1, 1993
Report Date
May 2, 1995
Manufacturer
JOHNSON & JOHNSON MEDICAL, INC.
Product Code
KGO
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THIS HEALTH CARE WORKER DEVELOPED A LATEX SENSITIVITY AND CAN NO LONGER WORK IN THE OR. SHE DIDN'T WEAR LATEX GLOVES FOR OVER 2 YEARS WHEN SHE HAD AN ADVERSE REACTION TO A BANANA AT HOME. SHE HAS NO OTHER ALLERGIES AT THE TIME OF HER REACTION. WHEN SHE RETURNED TO WORK ON THE NEXT DAY, SHE DEMANDED TO SEE AN ALLERGIST TO BE TESTED FOR A LATEX ALLERGY. SKIN PRICK TESTS FOUND HER SEVERELY ALLERGIC TO LATEX. SHE NOW WEARS A MEDICAL ID ALERT BRACELET AND CARRIES AN EPINEPHRINE PEN IN CASE OF ANAPHYLAXIS. SHE WAS EMPLOYED AT THE SAME HOSP FOR 8 1/2 YEARS AS A SURGICAL TECHNICIAN. HER CASE STARTED OUT WITH A RASH AND THEN HIVES ON HER HANDS AFTER WEARING LATEX GLOVES WITH A VERY HIGH CONTENT OF NATURAL RUBBER PROTEIN FOR ABOUT 6 1/2 YEARS. SHE THEN SWITCHED TO A HYPOALLERGENIC OR POWDER-FREE LATEX GLOVE THINKING THAT IT WAS THE POWDER IN THE GLOVES THAT CAUSED HER REACTION. THE SYMPTOMS WORSENED. SHE HEARD ABOUT LATEX ALLERGIES AND SO SWITCHED TO A LATEX-FREE GLOVE. HIVES AND ITCHING CEASED. ABOUT 2 MONTHS AGO, SHE ATE A BANANA AT HOME. ITCHING, SNEEZING, RASH, SWELLING OF LIPS, AND WHEEZING OCCURRED. BENADRYL WAS ADMINISTERED ORALLY. RUBBER PLANTS AND BANANA TREES HAVE THE SAME PROTEINS, THEREFORE SHE WAS NOW CROSS-REACTING OVER INTO THE FOODS SHE ATE. SHE SAW AN ALLERGIST, AND HASN'T WORKED IN THE OR SINCE 3/16/95. SYMPTOMS OF SNEEZING, WATERY EYES AND RUNNY NOSE QUIT. SHE WENT FOR A SECOND OPINION WHERE BLOOD TESTS AND SPIROMETRY WERE DONE WITH THE SAME FINDINGS. REPEAT PULMONARY FUNCTIONS WILL BE DONE IN ONE MONTH. IF SYMPTOMS WORSEN, SHE MAY NOT BE ABLE TO WORK IN A HOSP AT ALL. SHE NOW HOLDS A SECRETARIAL POSITION IN THE NURSING OFFICE OF THE SAME HOSP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NEUTRALON SURGEON'S GLOVE LATEX GLOVES KGO JOHNSON & JOHNSON MEDICAL, INC.

Patients

Seq Age Sex Outcome Treatment
1 25 YR Life Threatening| S