FDA Adverse Event
Injury
Summary report: N
NEBPAK GIRL ULTRASONIC NEBULIZER
MDR report key: 2626357
·
Received June 19, 2012
Report
- Report Number
- 1219232-2012-00006
- Event Type
- Injury
- Date Received
- June 19, 2012
- Date of Event
- April 23, 2012
- Report Date
- June 18, 2012
- Manufacturer
- VEGA TECHNOLOGIES INC.
- Product Code
- CAF
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATED THAT A CHILD PATIENT HAD AN ALLERGIC REACTION TO THE PRODUCT. THE PATIENT HAS USED ELECTRIC NEBULIZERS BEFORE. SHORTLY AFTER STARTING TO THIS PARDICULAR PRODUCT, HER FACE PUFFED UP AD HER EYES SWELLED SHUT. THE GIRL WAS TAKEN TO THE HOSPITAL. THERE HAVE BEEN NO OTHER CHANGES IN THE GIRL'S HISTORY OR MEDICAL TREATMENT OTHER THAN THE NEBULIZER. NUMEROUS ATTEMPTS TO OBTAIN FURTHER DETAILS HAVE BEEN UNSUCCESSFUL. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEBPAK GIRL ULTRASONIC NEBULIZER | NEBULIZER | CAF | VEGA TECHNOLOGIES INC. | 40-366-000 | 4774200711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |