MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for SO CLEAN OZONE CLEANER manufactured by Soclean, Inc..
[185710634]
Pt called this dme for urgent care due to reactive airway exacerbation and sinus infection diagnosis. Pt was prescribed antibiotics for infection and prednisone for airway swelling. Pt came in and described problem and insisted he cleans his pap equipment regularly but wanted it checked for any problems. Having brought his unit into this dme, upon inspection i noted a common ozone cleaner adaptive lid replacement for his pap humidifier. He stated this was for his so clean device. I then showed him both the resmed amended warranty and an article from (b)(6) reporting on the fda stance of ozone cleaners as well as uv light cleaners. Pt was surprised and stated he will stop use immediately. Pt reported going to urgent care twice more the week of this appt for pulmonary assessment of severe cough and was feeling better after having stopped the ozone cleaning routine within days after that. I have since learned of this service. I am not aware of any specific testing as it is outside of my scope of practice to check. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093964 |
| MDR Report Key | 9897308 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-04 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SO CLEAN OZONE CLEANER |
| Generic Name | DISINFECTANT, MEDICAL DEVICES |
| Product Code | LRJ |
| Date Received | 2020-03-27 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOCLEAN, INC. |
| Manufacturer Address | PETERBOROUGH NH 03458 US 03458 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-27 |