FDA Adverse Event
Injury
Summary report: N
BLOM-SINGER
MDR report key: 6817222
·
Received August 24, 2017
Report
- Report Number
- 2025182-2017-00002
- Event Type
- Injury
- Date Received
- August 24, 2017
- Date of Event
- December 15, 2015
- Report Date
- May 15, 2017
- Manufacturer
- FREUDENBERG MEDICAL, LLC
- Product Code
- EWL
- PMA / PMN Number
- K930105
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS ORIGINALLY SUBMITTED ON 5/15/2017, 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
WHILE INVESTIGATING ANOTHER PREVIOUSLY REPORTED EVENT (B)(4), IT WAS DISCOVERED THAT THE PATIENT HAD ASPIRATED ANOTHER PROSTHESIS IN (B)(6)2015. THE DEVICE WAS A PATIENT CHANGEABLE VOICE PROSTHESIS (B)(4); THE EXACT LOT NUMBER IS UNKNOWN, HOWEVER, IT IS EITHER 0000002776 OR 0000010285. THE DEVICE WAS REMOVED FROM THE PATIENT THROUGH BRONCHOSCOPY IN (B)(6) 2015. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596904 | BLOM-SINGER | VOICE PROSTHESIS | EWL | FREUDENBERG MEDICAL, LLC | 0000002776/0000010285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |