FDA Adverse Event
Injury
Summary report: N
CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1 MM TIP
MDR report key: 2492648
·
Received March 12, 2012
Report
- Report Number
- 2523190-2012-00023
- Event Type
- Injury
- Date Received
- March 12, 2012
- Report Date
- March 12, 2012
- Manufacturer
- INTEGRA YORK PA, INC.
- Product Code
- GEH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
THE NURSE MANAGER SAID THE NURSE PRACTITIONER "BURNED" HER FINGER WITH THE NITROGEN WHICH LEAKED ONTO HER FINGER WHEN SHE INSERTED THE WAND. THIS CAUSED A RED SPOT WHICH HAS SINCE HEALED. THERE WAS NO TREATMENT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1 MM TIP | M3-DERMAL | GEH | INTEGRA YORK PA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |