FDA Adverse Event
Malfunction
Summary report: N
81-020409 GENERAL PURPOSE PROBE YSI400
MDR report key: 431047
·
Received December 2, 2002
Report
- Report Number
- 1046367-2002-00005
- Event Type
- Malfunction
- Date Received
- December 2, 2002
- Report Date
- October 30, 2002
- Manufacturer
- DEROYAL SINDUSTRIES, INC.
- Product Code
- FLL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PROBES ARE TOO HARD. THEY CAUSE NOSE BLEEDS WHEN USED NASALLY. THE PROBES ARE TOO LONG. AFTER 30-45 MINS. THE PROBES BECOME VERY ERRATIC AS THOUGH SOMETHING HAS BURNT THROUGH ON THE ELECTRONICS OR THERE IS NO CONTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 81-020409 GENERAL PURPOSE PROBE YSI400 | NASAL/RECTAL PROBES | FLL | DEROYAL SINDUSTRIES, INC. | NA | 26551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |