FDA Adverse Event
Malfunction
Summary report: N
CRYSTAL EAR HEARING AID
MDR report key: 168412
·
Received May 20, 1998
Report
- Report Number
- MW1013856
- Event Type
- Malfunction
- Date Received
- May 20, 1998
- Date of Event
- January 23, 1998
- Report Date
- May 14, 1998
- Manufacturer
- COMTRAD INDUSTRIES
- Product Code
- ESD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
TWO CRYSTAL EAR HEARING AIDS RECEIVED. THEY DID NOT WORK AND WERE RETURNED TO THE CO. COMPANY ADVERTISED " ABSOLUTE SATISFACTION OR MONEY BACK." REPEATED CALLS TO THE CO. AT 1-800-992-2966. ACCORDING TO THE RPTR THE CO SAYS ITEMS RECEIVED BACK AND HIS ACCOUNT WILL BE CREDITED, BUT THEY NEVER HAVE CREDITED HIS ACCOUNT. THIS CO'S ADVERTISEMENTS ARE RIDICULOUS AND SHOULD BE STOPPED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTAL EAR HEARING AID | HEARING AID | ESD | COMTRAD INDUSTRIES | * | * | |
| 2 | CRYSTAL EAR HEARING AID | HEARING AID | ESD | COMTRAD INDUSTRIES | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |