FDA Adverse Event
Other
Summary report: N
STARKEY
MDR report key: 338339
·
Received June 15, 2001
Report
- Report Number
- 2125608-2001-00001
- Event Type
- Other
- Date Received
- June 15, 2001
- Date of Event
- June 4, 2001
- Report Date
- June 13, 2001
- Manufacturer
- STARKEY LABORATORIES, INC.
- Product Code
- ESD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
ON A CERTAIN OCCASION IN 2001 PATIENT WAS SEEN BY ENT AT HEARING AID DISPENSER'S OFFICE. THIS VISIT WAS PART OF A 4 WEEK SERIES OF FOLLOW-UP VISITS TO REMOVE BLOCKAGE FROM LEFT EAR. BLOCKAGE WAS DIAGNOSED BY ENT AS EAR WAX. WHEN BLOCKAGE WAS REMOVED, ENT DISCOVERED IT WAS NOT EAR WAX, BUT THE SOFT-FLEX TIP FROM A HEARING AID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27288 | STARKEY | IN-THE-EAR HEARING AID | ESD | STARKEY LABORATORIES, INC. | SECRET EAR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |