3M(TM) VFLEX(TM) HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK
Received Jan 6, 2017 · Event occurred Oct 30, 2016
Report 2110898-2017-00003 · MDR key 6231103
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
45 YR
- Itching Sensation
- Rash
- Skin Irritation
- Itching Sensation
- Rash
- Skin Irritation
Narrative
Additional Manufacturer Narrative
IT WAS NOT CLEAR IF MASK USED BY THE USER WAS USED MORE THAN ONE DAY. IMPROPER STORAGE MAY HAVE CONTRIBUTED TO THIS EVENT. IT WAS NOT CLEAR WHAT TYPE OF SEALED BAG THE FACILITY WAS USING TO STORE MASK IN NOR IF PRODUCT LINKED TO EVENT WAS STORED IN THE SEALED BAG.
Description of Event or Problem
A REPORT AND QUESTIONNAIRE WAS RECEIVED FROM A FEMALE NURSE ON (B)(6) 2016. THE FEMALE NURSE ALLEGE THAT ON (B)(6) 2016 SHE IMMEDIATELY BROKE OUT IN A RASH, AND HAD REDNESS, EXPERIENCED ITCHING AROUND HER EYES AND NECK AND UNDER THE MASK SHE WAS WEARING. SHE ALLEGED SHE HAD DONNED A 3M¿VFLEX¿HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK. SHE HAD USED A MASK FOR 2 DAYS WITHOUT ANY INCIDENT. NOTE: IT WAS NOT CLEAR IF IT WAS THE SAME, NEW OR DIFFERENT MASK. THE FEMALE WAS SEEN IN THE EMERGENCY ROOM ON THE DAY OF THE INCIDENT WHERE SHE WAS GIVEN DECADRON (DEXAMETHASONE) (ROUTE NOT SPECIFIED), BENADRYL (DIPHENHYDRAMINE), AND PEPCID (FAMOTIDINE). IT WAS INDICATED THE MASK WAS STORED IN A SEALED BAG. SHE CLAIMED TO HAVE NO KNOWN ALLERGIES. SHE REPORTED THERE WERE NO KNOWN ENVIRONMENTAL ISSUES AT THE TIME OF THE REACTION. THE DOCTOR WHO ATTENDED THE NURSE STATED SHE, "MAY HAVE AN ALLERGY TO THE RUBBER CONTENTS OF THE MASK". NOTE: INITIAL INFORMATION RECEIVED ON (B)(6) 2016 DID NOT INDICATE THE NATURE OF MEDICAL INTERVENTION. IT DID INCLUDE INFORMATION THAT SUGGESTED THE NURSE MAY HAVE AN ALLERGY TO RUBBER CONTENTS OF THE MASK DUE TO REACTION AROUND EYES AND NECK. PLEASE NOTE THE 3M¿VFLEX¿HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK IS NOT MADE WITH NATURAL RUBBER LATEX.