FDA Adverse Event
Injury
Summary report: N
OXYMASK
MDR report key: 15320409
·
Received August 30, 2022
Report
- Report Number
- 8022003-2022-00003
- Event Type
- Injury
- Date Received
- August 30, 2022
- Report Date
- August 30, 2022
- Manufacturer
- SOUTHMEDIC INC.
- Product Code
- BYG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
MASK HAD BEEN PLACED ON PATIENT FOR AROUND 18 HOURS BEFORE REMOVAL AND IDENTIFICATION OF BLISTERING. THERE WAS NO DOCUMENTATION OF ANYONE PUTTING ANY LOTION, CREAM, ETC. ON THE SKIN OF THE FACE. PATIENT REPORTS NO KNOWN ALLERGIES. ASSOCIATED FACILITIES TO THE INITIAL HEALTH FACILITY REPORTS NO SKIN ISSUES WITH USING THE DEVICE.
Description of Event or Problem · 0
PATIENT DEVELOPED FACIAL BLISTERS IN THE SHAPE OF THE OXYGEN MASK AFTER 18 HOURS OF USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148637 | OXYMASK | MASK, OXYGEN | BYG | SOUTHMEDIC INC. | OP-1125-8 | W82352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |