FDA Adverse Event
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 2993407
·
Received March 7, 2013
Report
- Report Number
- 1531186-2013-00935
- Date Received
- March 7, 2013
- Report Date
- February 11, 2013
- Manufacturer
- MEDEL S.P.A.
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
A REPRESENTATIVE FOR THE CONSUMER REPORTED THAT THE COMPRESSOR IS GETTING WATER IN IT WHICH IS GETTING INTO HER MOTHER'S MOUTH AS SHE IS USING IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96832 | PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES | 868.6250 | BTI | MEDEL S.P.A. | IRC1710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |