FDA Adverse Event
Malfunction
Summary report: N
HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV
MDR report key: 2241447
·
Received August 17, 2011
Report
- Report Number
- 3004365956-2011-00321
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 10, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE NEBULIZER IS LEAKING FROM THE CUP. ALLEGED DEFECT OCCURRED DURING PATIENT TREATMENT. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV | NEBULIZER | CAF | TELEFLEX MEDICAL | 02A1102775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |