FDA Adverse Event
Malfunction
Summary report: N
CHATTANOOGA
MDR report key: 4861665
·
Received June 19, 2015
Report
- Report Number
- 9616086-2015-00015
- Event Type
- Malfunction
- Date Received
- June 19, 2015
- Date of Event
- June 4, 2015
- Report Date
- April 4, 2016
- Manufacturer
- GBO MEDIZINTECHNIK AG
- Product Code
- IMJ
- PMA / PMN Number
- K0883433
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FDA ACKNOWLEDGED RECALL #Z-0121-2016 IN PROCESS AS A RESULT OF THIS AND SIMILAR INCIDENCES.
Description of Event or Problem · 1
COMPLAINT RECEIVED FROM CUSTOMER THAT ALLEGES "MONODE SMOKING, HAS A BURNING SMELL". QUESTIONNAIRE WAS NOT RECEIVED FROM CLINICIAN AND/OR PT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVAL. NO INDICATION EVENT CAUSED OR CONTRIBUTED TO PERMANENT IMPAIRMENT OR DEATH. NO INDICATION DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400663 | CHATTANOOGA | MONODE | IMJ | GBO MEDIZINTECHNIK AG | 02200002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |