FDA Adverse Event
Injury
Summary report: N
DIGNACAP
MDR report key: 17441805
·
Received August 2, 2023
Report
- Report Number
- 3012146457-2023-00007
- Event Type
- Injury
- Date Received
- August 2, 2023
- Date of Event
- July 31, 2023
- Report Date
- August 2, 2023
- Manufacturer
- DIGNITANA INC.
- Product Code
- PMC
- PMA / PMN Number
- K191166
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A BURN ON THE FORHEAD AND THE NECK. THIS IS DUE TO THE HEADBAND NOT BEING WORN CORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1158055 | DIGNACAP | SCALP COOLING | PMC | DIGNITANA INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |