MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-05 for SHOULDERFLEX manufactured by Na.
[2240471]
My son was using a new shoulderflex massager (this version was purchased at a (b)(6)) and his arm got caught in the rotating device. He has a 6 inch scar now on his arm where the "fingers" tore off skin. He was able to pull the plug before more severe damage was done. I had to manually reverse the bar to extract his arm. Had he not unplugged the device i'm certain he could have had his arm broken. I'm submitting this after seeing reports of death and injury caused by the king version of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022119 |
| MDR Report Key | 2240767 |
| Date Received | 2011-09-05 |
| Date of Report | 2011-09-05 |
| Date of Event | 2011-02-11 |
| Date Added to Maude | 2011-09-13 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOULDERFLEX |
| Generic Name | BACK MASSAGER/MUSCLE MASSAGER |
| Product Code | ISA |
| Date Received | 2011-09-05 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NA |
| Manufacturer Address | NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-09-05 |