MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-28 for WAX VAC manufactured by Wax Vac Ear Cleaner.
[3529329]
I, (b)(6), have the wax vac. My son used it and the rubber tip got stock in his ear and his dad and i could not get it out, so we had to go to the er to get it out and also it is a highly chocking hazard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030362 |
| MDR Report Key | 3144869 |
| Date Received | 2013-05-28 |
| Date of Report | 2013-05-28 |
| Date of Event | 2013-05-26 |
| Date Added to Maude | 2013-06-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAX VAC |
| Generic Name | WAX VAC |
| Product Code | JYH |
| Date Received | 2013-05-28 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAX VAC EAR CLEANER |
| Manufacturer Address | P.O. BOX 3008 WALLINGFORD CT 06494 US 06494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-28 |