MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-23 for HAWAII SPORTSFLY TENS UNIT AS2015 manufactured by Shenzhen Astec Technology Co Ltd..
[98232172]
The very first time i used the device it caused severe pain to my back. I was in such excruciating pain that i could barely move. I bought this item from (b)(6) at the (b)(6) in (b)(6). They sell it in a box that says 'massager' and it is made by a company called (b)(6). The apparent 'owner' assured me that the product was fda cleared and they were also fda registered. He even went as far as showing me his company 'fda registration'. After doing some research i found out that they are not fda registered and he was showing me the registration information for the company that makes the product! The fda told me that as an initial importer they should be registered and pay a fee to legally import medical devices into the us. Apparently this company does not care about the law. Here is a link to the product that injured me. (b)(6) i hope that nobody else gets injured as a result of this company breaking fda regulations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074741 |
| MDR Report Key | 7214782 |
| Date Received | 2018-01-23 |
| Date of Report | 2018-01-22 |
| Date of Event | 2018-01-08 |
| Date Added to Maude | 2018-01-24 |
| 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 | HAWAII SPORTSFLY TENS UNIT |
| Generic Name | TENS UNIT |
| Product Code | GZJ |
| Date Received | 2018-01-23 |
| Model Number | AS2015 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN ASTEC TECHNOLOGY CO LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-01-23 |