FDA Adverse Event
Injury
Summary report: N
DIGNICAP
MDR report key: 18699669
·
Received February 13, 2024
Report
- Report Number
- 3012146457-2024-00004
- Event Type
- Injury
- Date Received
- February 13, 2024
- Date of Event
- February 7, 2024
- Report Date
- February 13, 2024
- Manufacturer
- DIGNITANA INC.
- Product Code
- PMC
- PMA / PMN Number
- K19111466
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT HAS A PRESSURE TYPE LESION FROM THE USE OF THE HEADBAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1284381 | DIGNICAP | SCALP COOLING | PMC | DIGNITANA INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |