FDA Adverse Event
Injury
Summary report: N
BLOM-SINGER
MDR report key: 6011511
·
Received October 7, 2016
Report
- Report Number
- 2025182-2016-00005
- Event Type
- Injury
- Date Received
- October 7, 2016
- Date of Event
- July 15, 2011
- Report Date
- October 7, 2016
- 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
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
WHILE PERFORMING A LITERATURE REVIEW ON SEPTEMBER 16, 2016, A JOURNAL ARTICLE WAS DISCOVERED REGARDING AN ASPIRATED CLASSIC 10 MM INDWELLING VOICE PROSTHESIS. THE ARTICLE STATED A PATIENT WAS CLEANING THE DEVICE WHEN IT CAME OUT, THE PATIENT TRIED TO REPLACE THE DEVICE AND WAS UNSUCCESSFUL. THE PATIENT WAS ADMITTED INTO THE DEPARTMENT OF OTOLARYNGOLOGY HEAD AND NECK SURGERY AT (B)(6) HOSPITAL IN (B)(6) 2011. THE ADMISSION WAS FOR SUSPECTED ASPIRATION OF THE PROSTHESIS. THE DEVICE WAS DISCOVERED IN THE LUNGS USING CHEST RADIOGRAPHY. THE DEVICE WAS SUBSEQUENTLY REMOVED USING FLEXIBLE BRONCHOSCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662316 | BLOM-SINGER | VOICE PROSTHESIS | EWL | FREUDENBERG MEDICAL, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |