FDA Adverse Event
Other
Summary report: N
BLOM-SINGER INDWELLING DUAL VALVE VOICE PROST
MDR report key: 2887632
·
Received November 30, 2012
Report
- Report Number
- 2025182-2012-00001
- Event Type
- Other
- Date Received
- November 30, 2012
- Date of Event
- October 23, 2012
- Report Date
- November 29, 2012
- Manufacturer
- HELIX MEDICAL, LLC
- Product Code
- EWL
- PMA / PMN Number
- K932120
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS STILL IN PROCESS OF GETTING TO MFR. VA HOSPITAL DOING THEIR OWN INVESTIGATION PRIOR TO SENDING.
Description of Event or Problem · 1
SLP WAS DIFFICULTY PLACING VOICE PROSTHESIS IN PT. UPON SECOND ATTEMPT, SLP NOTICED THE VOICE PROSTHESIS VALVE FLAP HAD DETACHED AND WAS RESTING ON THE POSTERIOR WALL OF THE PT'S TRACHEA. PHYSICIAN/ENT REMOVED VALVE FLAP WITH A FLEXIBLE LARYNGOSCOPE AND SUCTION APPARATUS. THERE WAS NO INJURY TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLOM-SINGER INDWELLING DUAL VALVE VOICE PROST | EWL | HELIX MEDICAL, LLC | 1030667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |