FDA Adverse Event
Injury
Summary report: N
BLOM-SINGER
MDR report key: 6817253
·
Received August 24, 2017
Report
- Report Number
- 2025182-2016-00009
- Event Type
- Injury
- Date Received
- August 24, 2017
- Report Date
- January 27, 2017
- Manufacturer
- FREUDENBERG MEDICAL, LLC
- Product Code
- EWL
- UDI-DI
- 00813307010098
- 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 1/27/2017, 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) 2016; THEY HAD A VOICE PROSTHESIS THAT HAD A "FLAP" THAT "CURLED" CAUSING FLUIDS TO BE ASPIRATED. THE FLUID ASPIRATING THEN LEAD TO PNEUMONIA. FOLLOW UP WAS CONDUCTED WITH THE PATIENT AND IT WAS CONFIRMED THEY RECEIVED TREATMENT FOR PNEUMONIA FOLLOWING FLUID ASPIRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 597294 | BLOM-SINGER | VOICE PROSTHESIS | EWL | FREUDENBERG MEDICAL, LLC | 00813307010098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |