FDA Adverse Event
Injury
Summary report: N
DIGNICAP
MDR report key: 17819309
·
Received September 26, 2023
Report
- Report Number
- 3012146457-2023-00010
- Event Type
- Injury
- Date Received
- September 26, 2023
- Date of Event
- September 6, 2023
- Report Date
- September 26, 2023
- Manufacturer
- DIGNITANA INC
- Product Code
- PMC
- PMA / PMN Number
- K191166
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
PATIENT WORE THE HEADBAND BUT STILL RECEIVED A BURN ON THE NECK, THE BURN WAS BELOW THE HEADBAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1096673 | DIGNICAP | SCALP COOLING | PMC | DIGNITANA INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |