FDA Adverse Event
Injury
Summary report: N
WAX BLASTER MD
MDR report key: 16071385
·
Received December 29, 2022
Report
- Report Number
- 3013559620-2022-00001
- Event Type
- Injury
- Date Received
- December 29, 2022
- Date of Event
- November 25, 2022
- Report Date
- December 28, 2022
- Manufacturer
- EOSERA INC.
- Product Code
- OGQ
- UDI-DI
- 00851722007095
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
EAR SYRINGING IS A COMMON CLINICAL PROCEDURE IN PRIMARY HEALTH CARE AND THERE ARE MANY AT HOME SYRINGES AVALIABLE.
Description of Event or Problem · 0
(B)(6) USED OUR PRODUCT AND SELF-DIAGNOSED HIS PERFORATED EAR DRUM. AT THE TIME OF CONTACTING EOSERA (B)(6) 2022 HE STATED HE IS FINE NOW. HE STATED THAT HE HAD SEEN A DOCTOR WHO CONFIRMED HIS PERFORATED EAR DRUM. HE HAD ALSO STATED HE USED IT ON HIS CHILDREN WHO HAD NO PROBLEMS. UPON MEDICAL SAFETY FOLLOW-UP CALL ON 12/04/2022 BY OUR MEDICAL SAFETY OFFICER, (B)(6) REPEATED THAT HE HAD NO FURTHER PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2355076 | WAX BLASTER MD | EAR RINSE SYSTEM | OGQ | EOSERA INC. | X223123 | 00851722007095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Male | Other |