FDA Adverse Event
Malfunction
Summary report: N
AQUASONIC 100 ULTRASOUND TRANSMISSION GEL
MDR report key: 47525
·
Received November 4, 1996
Report
- Report Number
- 2212018-1996-00001
- Event Type
- Malfunction
- Date Received
- November 4, 1996
- Date of Event
- September 4, 1996
- Report Date
- October 7, 1996
- Manufacturer
- PARKER LABORATORIES, INC.
- Product Code
- KNG
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SQUEEZE BOTTLE RUPTURED ALLOWING HEATED GEL TO SQUIRT OUT ON PT. POTENTIAL FOR BURN INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AQUASONIC 100 ULTRASOUND TRANSMISSION GEL | DISPENSER FOR ULTRASOUND TRANSMISSION GEL | KNG | PARKER LABORATORIES, INC. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |