MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-28 for VAC-1 WITH ASPIRATOR OPTION manufactured by Lightning Enterprises.
[4655591]
I have had excellent hearing all my life, but i needed earwax removed from both ears. The audiologist used a suction/vacuum device. When he placed the tip of the tube in my ear and turned on the machine, i flinched and immediately said it was too loud. I tried to push his hand away. He agreed the machine was loud but said the procedure would be quick and cause no damage. Wrong. I was almost completely deaf for several months and still have severely impaired hearing as confirmed by tests done in an ent office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036430 |
| MDR Report Key | 3846043 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-27 |
| Date of Event | 2013-09-03 |
| Date Added to Maude | 2014-06-04 |
| 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 |
| Health Professional | 0 |
| 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 | VAC-1 WITH ASPIRATOR OPTION |
| Generic Name | VAC-1 WITH ASPIRATOR OPTION |
| Product Code | JYH |
| Date Received | 2014-05-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIGHTNING ENTERPRISES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-05-28 |