MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-11 for OTOTEK manufactured by Earest, Inc.
[1796453]
The ototek earloop is inherently unsafe. I am a primary care physician. None of my pts have reported using this device. I saw it for sale in a (b)(6) pharmacy. Its packaging suggests that it is for removing earwax. It consists of a plastic ear curette with a hilt to keep from being inserted too far into the ear. While it would probably be impossible to reach the tympanic membrane with the device, it clearly is long enough to reach the delicate tissue of the bony section of the external ear canal. There, it will cause abrasions. Even an experienced physician or audiologist has a hard time not causing abrasions using an otoscope and professional grade curettes. Abrasions can lead to infections with potentially dire consequences. Take this off the market right away, please!
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019026 |
| MDR Report Key | 1964030 |
| Date Received | 2011-01-11 |
| Date of Report | 2011-01-11 |
| Date Added to Maude | 2011-01-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OTOTEK |
| Generic Name | OTOTEK LOOP |
| Product Code | JYQ |
| Date Received | 2011-01-11 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EAREST, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-11 |