MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-01 for PERSONAL STEAM INHALER ZL101 manufactured by Walgreens / Kaz Usa Inc., A Helen Of Troy Company.
[122660947]
On the morning of (b)(6) 2018, i plugged in (b)(6) personal steam inhaler, and after about 10 minutes using the inhaler to clear my sinus congestion, it popped in my face. The device didn? T break, but it popped like an explosion and i threw it away from my face. The steam and liquid splashed on my face. My face was burning, turned red and was getting swollen. So i went to (b)(6) emergency room in (b)(6). I was treated and released with 1st degree and 2nd degree burns. I don? T know why this device, item number #a53e0097, model #zl101, wic #(b)(4), svc code: (b)(4) popped and burned my face. I? M scheduled to see the (b)(6) clinic at (b)(6) on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080252 |
| MDR Report Key | 7926030 |
| Date Received | 2018-10-01 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-09-25 |
| Date Added to Maude | 2018-10-02 |
| 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 | PERSONAL STEAM INHALER |
| Generic Name | HUMIDIFIER / NON INOVASIVE PATIENT INTERFACE |
| Product Code | KFZ |
| Date Received | 2018-10-01 |
| Model Number | ZL101 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALGREENS / KAZ USA INC., A HELEN OF TROY COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-01 |