FDA Adverse Event
Malfunction
Summary report: N
MISTRAL-AIR PLUS (115V) BLOWER
MDR report key: 4576490
·
Received February 25, 2015
Report
- Report Number
- 3003312341-2015-00001
- Event Type
- Malfunction
- Date Received
- February 25, 2015
- Date of Event
- January 31, 2015
- Report Date
- February 25, 2015
- Manufacturer
- THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY
- Product Code
- DWJ
- PMA / PMN Number
- K101705
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAD DAMAGE TO THE HOUSING WITH REPORTED SHARP EDGES. THE DEVICE WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HOUSING HAD REPORTED EXPOSED SHARP EDGES FROM DAMAGE THAT OCCURRED TO THE HOUSING OF THE DEVICE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133439 | MISTRAL-AIR PLUS (115V) BLOWER | THERMAL REGULATING | DWJ | THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY | MA1100-PM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |