MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-13 for TURBO EAR SOUND AMPLIFIER 18862MSA30X manufactured by Golden Aim International Ltd..
[100157499]
Caller stated she and her brother purchased the turbo ear amplifier from (b)(6). Both devices were found to be defective. The caller and her brother cannot hear with their devices due to background noise.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075221 |
| MDR Report Key | 7269561 |
| Date Received | 2018-02-13 |
| Date of Report | 2018-02-13 |
| Date of Event | 2017-02-01 |
| Date Added to Maude | 2018-02-14 |
| 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 | TURBO EAR SOUND AMPLIFIER |
| Generic Name | HEARING AID, AIR CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-02-13 |
| Model Number | 18862MSA30X |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GOLDEN AIM INTERNATIONAL LTD. |
| Manufacturer Address | DEERFIELD BCH FL US |
| Brand Name | TURBO EAR SOUND AMPLIFIER |
| Generic Name | HEARING AID, AIR CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-02-13 |
| Model Number | 18862MSA30X |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GOLDEN AIM INTERNATIONAL LTD. |
| Manufacturer Address | DEERFIELD BCH FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-13 |