FDA Adverse Event
Malfunction
Summary report: N
HUDSON INCENTIVE SPIROMETER LUNG VOLUME EXERC.
MDR report key: 2182531
·
Received July 8, 2011
Report
- Report Number
- 3004365956-2011-00276
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- December 1, 2010
- Report Date
- June 15, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BWF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
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 UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE PRODUCTS HAD BROKEN MOUTH PIECES. COMPLAINT STATES THAT THE MOUTH PIECES WERE NOT USED ON PATIENTS. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON INCENTIVE SPIROMETER LUNG VOLUME EXERC. | INCENTIVE SPIROMETER | BWF | TELEFLEX MEDICAL | NA | 02M0902090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |