FDA Adverse Event
Other
Summary report: N
PETITE PLUS
MDR report key: 339921
·
Received June 29, 2001
Report
- Report Number
- 1416900-2001-00047
- Event Type
- Other
- Date Received
- June 29, 2001
- Date of Event
- May 1, 2001
- Report Date
- June 22, 2001
- Manufacturer
- BELTONE ELECTRONICS CRP.
- Product Code
- ESD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE HEARING AID (H/A) DISPENSER REPORTED THAT THE USER DEVELOPED AN EAR INFECTION ATTRIBUTED TO WEARING THE HEARING INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29627 | PETITE PLUS | HEARING AID | ESD | BELTONE ELECTRONICS CRP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |