MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-14 for SINUPULSE ELITE manufactured by .
[33853433]
I use a sinupulse elite nasal wash system and a resmed cpap with an integrated humidifier. I use distilled water in both devices. I have been using the sinupulse for about 2 years and the cpap for about 6 months. I suddenly developed a sinus infection which completely closed my eye. I was rushed to the emergency room and admitted to the hospital. I had two emergency surgeries on my eye and sinuses (two surgical teams at the same time). The drainage was cultured and determined to be pseudomonas. I had no recent procedures or hospitalizations. The diagnosis was orbital cellulitis/abcess and sinusitis caused by pseudomonas. Neither the sinupulse or resmed cpap warned of this possibility or discussed how to disinfect their machines. I used distilled water in both machines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058551 |
| MDR Report Key | 5305985 |
| Date Received | 2015-12-14 |
| Date of Report | 2015-12-14 |
| Date of Event | 2015-10-30 |
| Date Added to Maude | 2015-12-17 |
| 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 | SINUPULSE ELITE |
| Generic Name | NASAL IRRIGATOR |
| Product Code | KAR |
| Date Received | 2015-12-14 |
| Model Number | ELITE |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Brand Name | RESMED CPAP |
| Generic Name | CPAP MACHINE |
| Product Code | BZD |
| Date Received | 2015-12-14 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | RESMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2015-12-14 |