MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for WAXTRACTOR EAR WAX REMOVAL KIT manufactured by Unk.
[131476872]
I purchased a waxtractor ear wax removal kit from (b)(6) on (b)(6) 2018. After using this product, the tip attached to the hose connected to the water bottle shot into my ear after squeezing the bottle trigger. The tip lodged into my ear canal causing a severe and painful ear infection, that now has resulted into a ringing in my right ear. I have contacted both (b)(6) and kruworks llc the vendor but to no avail. Document number: (b)(4). Report number: (b)(4). Kruworks llc. Email kruworks on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082377 |
| MDR Report Key | 8186564 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-09-30 |
| Date of Event | 2018-09-17 |
| Date Added to Maude | 2018-12-20 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WAXTRACTOR EAR WAX REMOVAL KIT |
| Generic Name | WAXTRACTOR EAR WAX REMOVAL KIT |
| Product Code | OGQ |
| Date Received | 2018-12-19 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |