MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for N20 CPAP FACEMASK manufactured by Resmed Ltd.
[118825099]
Reporter states that in (b)(6) 2018, she began to use the n20 face mask and has experienced allergic reactions such as contact dermatitis, conjunctivitis and eye infections. She has developed a rash on her head, chin, neck, and ears. She also experienced visual disturbances and has stopped using the device a week ago and as a result, difficulty breathing returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079469 |
| MDR Report Key | 7826572 |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-02-01 |
| Date Added to Maude | 2018-08-29 |
| 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 | PATIENT |
| 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 | 0 |
| Brand Name | N20 CPAP FACEMASK |
| Generic Name | MASK, OXYGEN |
| Product Code | BYG |
| Date Received | 2018-08-28 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-28 |