MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-07 for SAMMONS PRESTON RESISTIVE PEDAL EXERCISER (FROM PO) NOT LABELED 925110 manufactured by Unk.
[130061989]
No mfr labeling on a resistive pedal exerciser sold by performance health. Outside box indicated it was "made in (b)(4)". User guide doesn't reflect who manufactured unit. Unk other than (made in (b)(4)).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081981 |
| MDR Report Key | 8147060 |
| Date Received | 2018-12-07 |
| Date of Report | 2018-11-14 |
| Date Added to Maude | 2018-12-10 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | SAMMONS PRESTON RESISTIVE PEDAL EXERCISER (FROM PO) |
| Generic Name | RESISTIVE PEDAL EXERCISER |
| Product Code | ION |
| Date Received | 2018-12-07 |
| Model Number | NOT LABELED |
| Catalog Number | 925110 |
| Lot Number | NOT LABELED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-12-07 |