MAUDE Adverse Event Report: SLEEP 8, INC. SLEEP 8 CPAP CLEANING COMPANION; DISINFECTANT, MEDICAL DEVICES

Model Number SLP82043

Device Problem Device Emits Odor (1425)

Patient Problems Fatigue (1849); Burning Sensation (2146); Weight Changes (2607); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/21/2020

Event Type  malfunction  

Event Description

Cpap cleaning machine.Sleep 8.Face mask (nose mask) had weird smell and burning sensation.Headache the following day, fatigue, bloating, weight gain.Have noticed this occurs after cleaning once/week.Fda safety report id# (b)(4).

• Brand Name: SLEEP 8 CPAP CLEANING COMPANION
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8, INC.
• MDR Report Key: 11010510
• MDR Text Key: 221540422
• Report Number: MW5098342
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 6022400263
• UDI-Public: 6022400263
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SLP82043
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ESTRADIOL; LEXAPRO; PROGESTERONE
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 78