MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for ASHLEY BLACK FASCIA BLASTER manufactured by Adb Interest Llc.
[122010547]
Used fascia blaster as directed and woke up the next day full of bruises. Having blood in my urine for 3 days. Went to the dr today. My legs ache and they are swollen. I also have bruises on my triceps and swollen. Ashley black.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080109 |
| MDR Report Key | 7910243 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-09-17 |
| Date Added to Maude | 2018-09-26 |
| 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 | ASHLEY BLACK FASCIA BLASTER |
| Generic Name | COMPONENTS, EXERCISE |
| Product Code | IOD |
| Date Received | 2018-09-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADB INTEREST LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-25 |