FDA Adverse Event
Malfunction
Summary report: N
BLOM-SINGER® CLASSIC INDWELLING 20 FR. VOICE PROSTHESIS, NON-STERILE, 10MM
MDR report key: 25111111
·
Received May 7, 2026
Report
- Report Number
- 2025182-2026-00002
- Event Type
- Malfunction
- Date Received
- May 7, 2026
- Date of Event
- April 10, 2026
- Report Date
- May 6, 2026
- Manufacturer
- FREUDENBERG MEDICAL LLC
- Product Code
- EWL
- UDI-DI
- 00813307011194
- PMA / PMN Number
- K932120
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
A DIRECT PATIENT COMPLAINT WAS LOGGED. HAD AN INCREASE OF CENTRAL LEAKAGE, THE PATIENT DEVELOPED PNEUMONIA AND WAS HOSPITALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144808 | BLOM-SINGER® CLASSIC INDWELLING 20 FR. VOICE PROSTHESIS, NON-STERILE, 10MM | VOICE PROSTHESIS | EWL | FREUDENBERG MEDICAL LLC | IN 2010-NS | 0000363470 | 00813307011194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization |