MASK PROCEDURE YELLOW
Received Dec 7, 2021 · Event occurred Jan 1, 1980
Report 1423537-2021-00694 · MDR key 12956663
Device
Generic name
Mask, Surgical
Manufacturer
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.Model number
AT70021Catalog number
AT70021
Lot number
21FQH614
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
AN INCIDENT WAS REPORTED FOR AN ASSOCIATE THAT EXPERIENCED AN ALLERGIC REACTION TO A CARDINAL HEALTH MASK. THE TEAM MEMBER HAD TO BE PRESCRIBED A 7-DAY TREATMENT OF PREDNISONE TO TREAT SEVERE DERMATITIS. WE HAVE NOT RECEIVED ANY ADDITIONAL FOLLOW UP AFTER SEVERAL REQUESTS.
Additional Manufacturer Narrative
A SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. WE HAVE VERIFIED THAT THESE DEVICES ARE MADE WITH QUALIFIED, TESTED, AND APPROVED MATERIALS. THIS PRODUCT WAS MADE TO MEET WITH THE SPECIFICATION REQUIREMENTS. THE FAILURE MODE AND EFFECT ANALYSIS APPLICABLE TO THIS PRODUCT WAS REVIEWED. IT WAS FOUND THAT THE PRODUCT IS NOT MADE WITH NATURAL RUBBER LATEX, AND THE PRODUCT IS LABELED FOR SINGLE USE. WITHOUT A SAMPLE A ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, WE WILL CONTINUE TO MONITOR TRENDS OF THIS TYPE OF INCIDENT.