Description of Event or Problem · 0
3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED BY A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER ADVISING THAT THEIR PATIENT HAD ALLEGED THAT A SIESTA FULL FACE MASK HAD CAUSED AN "ALLERGIC REACTION" AND/OR "BREAKOUTS" ON HER FACE. THE PATIENT WENT TO HER DOCTOR AND WAS PROVIDED WITH A PRESCRIPTION CREAM FOR TREATMENT. THERE WAS NO RESPIRATORY COMPROMISE OR LONG-TERM OR PERMANENT IMPAIRMENT/SCARRING. WHEN THE DME ASKED THE PATIENT HOW OFTEN SHE WAS CLEANING THE MASK, SHE ADVISED THE DME THAT SHE DOES NOT CLEAN IT. THE PATIENT STATED THAT SHE JUST REPLACES IT WHEN SHE RECEIVES A NEW ONE. THE DME RE-EDUCATED THE PATIENT ON THE IMPORTANCE OF CLEANING THE MASK DAILY, OR AFTER EACH USE. THE DME ALSO CONTACTED THE DOCTOR WHO TREATED THE PATIENT AND SPOKE TO HIS RN. THE DOCTOR/RN ADVISED THE DME THAT IT WAS THEIR OPINION THAT THE RASH WAS MOST LIKELY DUE TO THE PATIENT NOT CLEANING THE MASK. THE PATIENT HAS NOT RETURNED THE MASK TO 3B MEDICAL INC OR THE MANUFACTURER FOR AN EVALUATION AND DID NOT PROVIDE ANY INFORMATION REGARDING THE MASK BEING USED OTHER THAN THE BRAND NAME. AS A RESULT, SECTION D4 (MODEL NUMBER, CATALOG NUMBER, LOT NUMBER AND UDI NUMBER) ARE "UNKNOWN". THE SIESTA FULL FACE MASK USER MANUAL, V1.0, PAGE 1, STATES: "STOP USING THE SIESTA FULL FACE MASK AND CONSULT YOUR PHYSICIAN OR SLEEP THERAPIST IF YOU HAVE ANY ADVERSE REACTION TO THE USE OF THE MASK.¿ THE SIESTA FULL FACE MASK USER MANUAL, V1.0, PAGE 2, STATES THE FOLLOWING REGARDING CLEANING THE MASK: ¿DAILY / AFTER EACH USE DISASSEMBLE THE MASK COMPONENTS ACCORDING TO THE DISASSEMBLY INSTRUCTIONS. THOROUGHLY CLEAN THE SEPARATED MASK COMPONENTS (EXCLUDING HEADGEAR) BY GENTLY RUBBING IN WARM WATER (APPROX. 86°F / 30°C) USING MILD, UNSCENTED LIQUID DISH DETERGENT FOR UP TO 10 MINUTES. USE A SOFT BRISTLE BRUSH TO CLEAN THE VENT. RINSE ALL COMPONENTS WELL WITH DRINKING QUALITY WATER AND ALLOW THEM TO AIR DRY OUT OF DIRECT SUNLIGHT. WHEN ALL COMPONENTS ARE DRY, REASSEMBLE THE MASK ACCORDING TO THE REASSEMBLY INSTRUCTIONS. WEEKLY HANDWASH THE HEADGEAR AND ALL COMPONENTS IN WARM (APPROX. 86°F / 30°C), MILD, UNSCENTED LIQUID DISH DETERGENT FOR UP TO 10 MINUTES. RINSE THE COMPONENTS WELL WITH DRINKING QUALITY WATER AND ALLOW THEM TO AIR DRY OUT OF DIRECT SUNLIGHT BEFORE REASSEMBLING.¿ THE INVESTIGATION DETERMINED THAT THE CAUSE OF THE PATIENT¿S RASH WAS USER ERROR.