FDA Adverse Event
Malfunction
Summary report: N
CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP
MDR report key: 2512682
·
Received March 28, 2012
Report
- Report Number
- 2523190-2012-00030
- Event Type
- Malfunction
- Date Received
- March 28, 2012
- Report Date
- March 28, 2012
- Manufacturer
- INTEGRA YORK, PA INC.
- Product Code
- GEH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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
DR. WAS CHANGING CARTRIDGE ON UNIT. WHEN HE INSERTED THE NEW CARTRIDGE, THE GAS SHOT OUT AND BURNED HIS HAND IN THE THUMB AND FOREFINGER AREA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYOSOLUTIONS SET WITH 1 CARTRIDGE/1MM TIP | M3-DERMAL | GEH | INTEGRA YORK, PA INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |