FDA Adverse Event
Malfunction
Summary report: N
HUDSON INCENTIVE SPIROMETER
MDR report key: 2062488
·
Received March 21, 2011
Report
- Report Number
- 3004365956-2011-00112
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 27, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BWF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SAMPLE HAS BEEN RETURNED FOR INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE MOUTHPIECE WAS FOUND DAMAGED UPON INSPECTION. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON INCENTIVE SPIROMETER | INCENTIVE SPIROMETER | BWF | TELEFLEX MEDICAL | NA | 02H1000630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |