FDA Adverse Event
Malfunction
Summary report: N
HUDSON INCENTIVE SPIROMETER
MDR report key: 2102045
·
Received April 13, 2011
Report
- Report Number
- 3004365956-2011-00180
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 20, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BWF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
COMPLAINT ALLEGES THAT UPON INSPECTION (PRIOR TO PATIENT USE), THERE WAS A LARGE QUANTITY OF SPIROMETERS WITH A BROKEN/CRACKED MOUTHPIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON INCENTIVE SPIROMETER | SPIROMETER | BWF | TELEFLEX MEDICAL | NA | 02F1000275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |