MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-22 for MSA 30X HEARING AMPLIFIER 2997364 manufactured by Global Tv Concepts, Ltd..
[109161444]
I charged my hearing device for about 15-20 minutes then put it in my ear and heard a loud pop and felt a sudden pain, took it out and it had exploded open. Msa 30x hearing device with charger. / item #2997364 rechargeable 0. 3 ounces fits right or left ear adjustable volume control color tan with clear tubing and white ear piece / black charger. As seen on tv/ sold by buy from tv/ (b)(6). The product was damaged before the incident: no. The product was modified before the implant: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077400 |
| MDR Report Key | 7536823 |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-05-09 |
| Date Added to Maude | 2018-05-23 |
| 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 | MSA 30X HEARING AMPLIFIER |
| Generic Name | HEARING AID, AIR CONDUCTION |
| Product Code | ESD |
| Date Received | 2018-05-22 |
| Model Number | 2997364 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBAL TV CONCEPTS, LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-22 |