FDA Adverse Event
Injury
Summary report: N
BLOM-SINGER
MDR report key: 6817262
·
Received August 24, 2017
Report
- Report Number
- 2025182-2017-00001
- Event Type
- Injury
- Date Received
- August 24, 2017
- Date of Event
- March 15, 2017
- Report Date
- March 31, 2017
- Manufacturer
- FREUDENBERG MEDICAL, LLC
- Product Code
- EWL
- UDI-DI
- 008133707010098
- PMA / PMN Number
- K930105
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS ORIGINALLY SUBMITTED ON 3/31/2017, IN AN INCORRECT FORMAT. THIS WAS INITIALLY DISCOVERED ON 8/23/2017, AND THIS IS BEING RE-SUBMITTED ON 8/24/2017.
Description of Event or Problem · 1
PATIENT POSTED ON AN INTERNET BLOG ON (B)(6) 2017; THEY HAD A VOICE PROSTHESIS THAT WAS ASPIRATED. A PHYSICIAN WAS ABLE TO REMOVE THE VOICE PROSTHESIS FROM THE PATIENT'S LUNGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 597295 | BLOM-SINGER | VOICE PROTHESIS | EWL | FREUDENBERG MEDICAL, LLC | 0000045318 | 008133707010098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |