FDA Adverse Event
Malfunction
Summary report: N
PROBE
MDR report key: 738376
·
Received July 14, 2006
Report
- Report Number
- 2523835-2006-00006
- Event Type
- Malfunction
- Date Received
- July 14, 2006
- Date of Event
- June 14, 2006
- Report Date
- June 14, 2006
- Manufacturer
- ALCON PRECISION DEVICE-SINKING SPRING
- Product Code
- HJD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT/LOT NUMBER WAS NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
REPORTER NOTED ILLUMINATOR PROBE TIP MELTED. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROBE | PROBE | HJD | ALCON PRECISION DEVICE-SINKING SPRING | 8065010920 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | NI. |