FDA Adverse Event
Injury
Summary report: N
BLOM-SINGER
MDR report key: 6815794
·
Received August 23, 2017
Report
- Report Number
- 2025182-2017-00004
- Event Type
- Injury
- Date Received
- August 23, 2017
- Report Date
- August 23, 2017
- Manufacturer
- FREUDENBERG MEDICAL, LLC
- Product Code
- EWL
- PMA / PMN Number
- K932120
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CONTRACTOR DISCOVERED A WEBSITE SHOWING AN X-RAY OF AN ASPIRATED VOICE PROSTHESIS. BASED ON THE DIMENSIONS OF THE RADIOPAQUE RING, THE CONTRACTOR INDICATED THAT THE DEVICE WAS A CLASSIC INDWELLING VOICE PROSTHESIS. THE WEBSITE DID NOT SPECIFICALLY INDICATE THAT THE PROSTHESIS WAS A DEVICE MANUFACTURED BY FREUDENBERG MEDICAL. NO ADDITIONAL DETAILS CONCERNING THIS ADVERSE EVENT COULD BE FOUND ON THE WEBSITE. THE AUTHOR OF THE WEBSITE, A PHYSICIAN, WAS CONTACTED TO OBTAIN MORE INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS AVAILABLE SINCE THE X-RAY IMAGE DID NOT HAVE PATIENT IDENTIFIERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593878 | BLOM-SINGER | VOICE PROSTHESIS | EWL | FREUDENBERG MEDICAL, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |