FDA Adverse Event
Other
Summary report: N
BIOM-SINGER LOW PRESSURE V.P.
MDR report key: 441217
·
Received January 31, 2003
Report
- Report Number
- 2025182-2003-00002
- Event Type
- Other
- Date Received
- January 31, 2003
- Date of Event
- January 2, 2003
- Report Date
- January 14, 2003
- Manufacturer
- HELIX MEDICAL, INC.
- Product Code
- EWL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS PLACED WITH VOICE PROSTHESIS IN 2002 WITH THE STRAP TAPED TO THEIR NECK. THE NEXT DAY PT EXPERIENCED A VIOLENT COUGHING FIT. AFTER WIPING THEIR STOMA, PT NOTICED THE STRAP AND PROSTHESIS WERE NO LONGER VISIBLE. PT WENT TO THE DOCTOR, THE DOCTOR SAW THE STRAP INSIDE THE PUNCTURE BUT PUSHED THE DEVICE DOWN INTO ESOPHAGUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOM-SINGER LOW PRESSURE V.P. | VOICE PROSTHESIS | EWL | HELIX MEDICAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |