MASK SURGICAL FOGFREE ANTI GLARE
Received Apr 8, 2019 · Event occurred Mar 12, 2019
Report 1423537-2019-00305 · MDR key 8492342
Device
Generic name
Mask, Surgical
Manufacturer
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.Catalog number
AT74635-I
Lot number
NOT AVAILABLE
Product problems
- Patient-Device Incompatibility
Patient
47 YR
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
THE CUSTOMER COULD NOT PROVIDE THE LOT NUMBER. WITHOUT THE LOT NUMBER, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE CUSTOMER DISCARDED THE SAMPLE. WITHOUT THE SAMPLE, THE ROOT CAUSE COULD NOT BE IDENTIFIED. THESE DEVICES ARE MADE WITH QUALIFIED, TESTED, AND APPROVED MATERIALS. THE PRODUCT WAS MADE TO MEET SPECIFICATION REQUIREMENTS, AND IS NOT MADE WITH NATURAL RUBBER LATEX. A REVIEW OF THIS PRODUCT CATALOG NUMBER IDENTIFIED NO TRENDS FOR THIS ISSUE IN THE LAST TWELVE MONTHS. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR SUCH ISSUES. AWARENESS DOCUMENTED TRAINING WAS PROVIDED TO THE INVOLVED EMPLOYEES, AND THE QUALITY INSPECTOR WILL CONTINUE TO MONITOR THE PRODUCT.
Description of Event or Problem
NURSE STATES ¿DURING THE PROCEDURE MY NOSE WAS ITCHING, BY THE END OF THE DAY I HAD HIVES AROUND THE RIGHT SIDE OF MY MOUTH. THE NEXT DAY MY WHOLE FACE WAS SWOLLEN¿. SHE SAW A PHYSICIAN AND WAS TOLD TO KEEP TAKING BENADRYL EVERY 6 HOURS AND WAS PRESCRIBED A PREDNISONE PACK FOR 6 DAYS.