MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for ACCELERATED PERFORMANCE RECOVERY (ARP) MACHINE manufactured by Unk.
[182366733]
Chiropractor had me hooked up to a machine called accelerated performance recovery (arp) for electric stimulation for sore shoulder. After 3 mins, i blacked out, a total faint for a few mins. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093511 |
| MDR Report Key | 9786070 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-29 |
| Date of Event | 2020-02-18 |
| Date Added to Maude | 2020-03-04 |
| 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 | 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 | 3 |
| Brand Name | ACCELERATED PERFORMANCE RECOVERY (ARP) MACHINE |
| Generic Name | STIMULATOR, MUSCLE, POWERED |
| Product Code | IPF |
| Date Received | 2020-03-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |