FDA Adverse Event
Malfunction
Summary report: N
DYMO LABEL/WRITER SE 300
MDR report key: 2113869
·
Received May 18, 2011
Report
- Report Number
- 2248721-2011-00066
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Report Date
- April 27, 2011
- Manufacturer
- DYMO
- Product Code
- ILQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - METHOD: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ITC REPLACED THE PRINTER, LABEL MAKER. RESULTS: COMPLAINT COULD NOT BE CONFIRMED. CONCLUSIONS: THE PRINTER AND THE LABEL MAKER ARE NOT MANUFACTURED BY ITC. NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTS THAT THEIR PRINTER HAS A SMELL OF BURNING AND DATA WAS NOT PRINTED". NO ADVERSE EVENT(S) REPORTED. THIS EVENT OCCURRED OUTSIDE THE US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DYMO LABEL/WRITER SE 300 | NONE | ILQ | DYMO | SE300 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |