FDA Adverse Event
Malfunction
Summary report: N
HUDSON MICRO MIST NEBULIZER W/ TEE
MDR report key: 1963669
·
Received December 21, 2010
Report
- Report Number
- 3004365956-2010-00374
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Report Date
- December 1, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER FOR EVALUATION, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE DEVICE IS NOT NEBULIZING PROPERLY. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON MICRO MIST NEBULIZER W/ TEE | NEBULIZER | CAF | TELEFLEX MEDICAL | NA | 02H1000898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |