FDA Adverse Event
Malfunction
Summary report: N
HUDSON INCENTIVE SPIROMETER LUNG/VOL EXERCISER
MDR report key: 2113816
·
Received May 17, 2011
Report
- Report Number
- 3004365956-2011-00207
- Event Type
- Malfunction
- Date Received
- May 17, 2011
- Date of Event
- April 14, 2011
- Report Date
- May 2, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BWF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY MFR AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGED THAT THE MOUTH PIECES ON THE SPIROMETER WERE BROKEN. THE ALLEGED DEFECT WAS DISCOVERED UPON INCOMING INSPECTION. THERE WAS NO PT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON INCENTIVE SPIROMETER LUNG/VOL EXERCISER | SPIROMETER LUNG VOLUME EXERCISER | BWF | TELEFLEX MEDICAL | NA | 02J1001994 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |