SLEEP 8 Adverse Event — Injury (MDR MW5094288)
SLEEP 8 Adverse Event — Injury (MDR MW5094288) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SLEEP 8; Generic name: DISINFECTANT, MEDICAL DEVICES; Manufacturer: UNK.
| Device | SLEEP 8 |
|---|---|
| Generic name | DISINFECTANT, MEDICAL DEVICES |
| Manufacturer | UNK |
| Report number | MW5094288 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | I'VE BEEN USING O ZONE BASED SANITIZING SYSTEM FOR CPAP UNDER THE BRAND NAME "SLEEP 8". HAVE HAD BREATHING PROBLEMS INCLUDING WHEEZING AND STINGING WHEN INHALING FOLLOWING USE OF THE SLEEP 8 SYSTEM. DO NOT PRESENT THESE SYMPTOMS WHEN I JUST WASH THE CPAP SYSTEM WITH SOAP AND WATER PER MANUFACTURER INSTRUCTIONS. I HAVE ALSO DEVELOPED A RASH AROUND WHERE MY MASK CONTACTS MY FACE. FDA SAFETY REPORT I |
| Source | openFDA MAUDE (device adverse events) |
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