MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-09 for EARVAC manufactured by .
[5411154]
A mother of a (b)(6) reported that she was using earvac to extract water from her son's ears when he was (b)(6). The tip of the rubber piece stuck in his ears. She had to take him to the emergency room and the piece was removed surgically. She said the device was left at the hospital. She is wondering why the device is still on the market and suggesting it should be pulled from the shelves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040664 |
| MDR Report Key | 4508606 |
| Date Received | 2015-02-09 |
| Date of Report | 2015-02-09 |
| Date Added to Maude | 2015-02-12 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 |
| Generic Name | EARVAC |
| Product Code | JZF |
| Date Received | 2015-02-09 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-09 |