FDA Adverse Event Malfunction Summary report: N

3M 1812 ASEPTEX MASK

MDR report key: 39720 · Received March 21, 1995

Report

Report Number
39720
Event Type
Malfunction
Date Received
March 21, 1995
Date of Event
February 15, 1995
Report Date
March 17, 1995
Manufacturer
3M MEDICAL SURGICAL DIV 3M HEALTHCARE
Product Code
FXX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

INPATIENT NURSE DEVELOPED REDNESS, TINGLING, AND SWELLING OF THE LIPS, AS WELL AS EYE SWELLING AND ITCHING AFTER WEARING A MASK (SUB-MICRON MOLDED SURGICAL MASK). THIS WAS THE FIRST TIME THE EMPLOYEE USED THIS TYPE AND MODELS OF MASK. THE EMPLOYEE HAD WORN THE MASK FOR 15-20 MINUTES. EMPLOYEE WAS TREATED FOR AN ANAPHYLACTIC REACTION IN THE EMERGENCY ROOM IMMEDIATELY FOLLOWING THE INCIDENT. THE EMPLOYEE WAS ALSO TREATED FOR COUGHING AND WHEEZING ON FOUR DIFFERENT DATES FOLLOWING THE INITIAL INCIDENT ON 2/15/95. PT TO ER AFTER WEARING MASK DEVELOPED REDNESS AND TINGLING AND SWELLING OF THE LIPS, EYES SWELLING AND ITCHING. NO SHORTNESS OF BREATH, LUNGS CLEAR TO AUSCULTATION BILATERALLY. EMPLOYEE HAD WORN THE MASK FOR ABOUT 15-20 MINUTES WHILE CHANGING AN ISOLATION PT'S BED. WHILE IN ER, SHE HAD PROGRESSIVE EYE SWELLING AND ITCHING. SHE WAS TREATED WITH BENADRYL 25 MGM (IM) AT 1140; EPINEPHRINE .5 MGM (SQ) @ 1215; SOLU CORTEF 125 MGM (IV). HOME @ 1410 ON PREDNISONE 60 MGM (PO) DAILY X 7 DAYS AND BENADRYL 25 MGM QID PRN. 2/24/95-COUGHING AND WHEEZING; TO ER FOR COUGH RX. GIVEN BENADRYL SYR. NO SIGNIFICANT DYSPNEA, PER DR'S NOTE. NO HISTORY OF REACTIVE AIRWAY DISEASE. CHEST X-RAY RELATED TO THE MASK. HOME @ 2120 ON PROVENTIL INHALER AND TOLD TO RETURN PRN WHEEZING. WAS TREATED IN ER WITH SOLUCORTEF 125 MGM IM AND A BREATHING TREATMENT. 2/26/95 @ 0900-TO ER WITH WHEEZING. TREATED WITH ALBUTEROL TREATMENT X 2. HOME @ 1030 WITH URI/RAD. 2/27/95 @ 0915-TO ER WITH WHEEZING. DR FOUND CHEST WITH DIFFUSE WHEEZING. TREATED WITH ALBUTEROL. HOME @ 1015 WITH ASTHMACIRT AND ALBUTEROL, AND ERYTHROMYCIN 250 MGM QID. NOTE HAS ALLERGIES TO MELLARIL, BEE STINGS, ADHESIVE TAPE, MORPHINE, AND CODEINE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 3M 1812 ASEPTEX MASK SUB-MICRON MOLDED SURGICAL MASK FXX 3M MEDICAL SURGICAL DIV 3M HEALTHCARE 1812 JUL 93 3197

Patients

Seq Age Sex Outcome Treatment
1 50 YR Other