FDA Adverse Event
Injury
Summary report: N
MISTRAL-AIR
MDR report key: 3672071
·
Received February 26, 2014
Report
- Report Number
- 3003312341-2014-00002
- Event Type
- Injury
- Date Received
- February 26, 2014
- Date of Event
- January 28, 2014
- Report Date
- February 26, 2014
- Manufacturer
- THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY
- Product Code
- DWJ
- PMA / PMN Number
- K101705
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EVALUATED BY THE IMPORTER STRYKER MEDICAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN A PHYSICIAN ATTEMPTED TO REATTACH THE BLOWER HOSE THEY WERE POKED IN THE FINGER BY WIRE THAT WAS AT THE HOSE END. IT WAS REPORTED THAT THE PHYSICIAN REQUIRED A TETANUS SHOT AS RESULT OF THE POKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117378 | MISTRAL-AIR | THERMAL REGULATING | DWJ | THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY | MISTRAL-AIR PLUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |