FDA Adverse Event
Injury
Summary report: N
WELL AT WALGREENS
MDR report key: 6247762
·
Received January 12, 2017
Report
- Report Number
- 1460851-2017-00001
- Event Type
- Injury
- Date Received
- January 12, 2017
- Report Date
- January 12, 2017
- Manufacturer
- BIGWALL ENTERPRISES
- Product Code
- KFZ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CONSUMER INDICATED THAT HOT WATER FROM THE PRODUCT EXPLODED WHILE SHE WAS USING THE PRODUCT, CAUSING BURNS TO HER EYES AND FACE. SHE INDICATED THAT SHE WENT TO THE HOSPITAL AND THEY TREATED HER WITH MORPHINE. SHE ALSO INDICATED THAT SHE COULD NOT OPEN HER EYES FOR THREE DAYS AND HER EYESIGHT APPEARED TO BE COMPROMISED. SHE INDICATED SHE WOULD BE VISITING AN OPHTHALMOLOGIST FOR FURTHER FOLLOW-UP. THIS PRODUCT HAD BEEN PREVIOUSLY RECALLED IN NOVEMBER 2015 AND HAS NOT BEEN SOLD AT WALGREENS STORES SINCE THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30435 | WELL AT WALGREENS | PERSONAL STEAM INHALER | KFZ | BIGWALL ENTERPRISES | PJ1011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |