InjuryBYP
RESPIRONICS, INC.
Received Dec 21, 2010 · Event occurred Jan 1, 2008
Report MW5018690 · MDR key 1938534
Device
Generic name
Comfortgel Mask W/hgr, Dom Size Small
Manufacturer
Respironics, Inc.Model number
HCPCS A7034Catalog number
REF 1009041
Lot number
101102
Product problems
- Fumes or Vapors
Patient
51 YR
- Respiratory Distress
Narrative
Description of Event or Problem
INCREASING REACTION TO THE TOXIC FUMES THAT CHINESE MADE COMFORTGEL NASAL MASK BY RESPIRONICS INC DISCHARGES TO THE POINT THAT I SUFFOCATE FROM COMPLETE AIRWAY BLOCKAGE DURING SLEEP. THIS MASK WAS PROVIDED TO ME BY (B)(6). I HAVE COMPLAINED NUMEROUS TIMES TO (B)(6) SLEEP LAB TECHS, DR. (B)(6), AT NO AVAIL. DOSE OR AMOUNT: SLEEP APNEA TREATMENT, FREQUENCY: EVERY DAY. DATES OF USE: COMFORTGEL NASAL MASK FOR CPAP SINCE 2008. DIAGNOSIS OR REASON FOR USE: OBSTRUCTIVE SLEEP APNEA.