MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-02-06 for ELEVATING LEGREST W/ADJ CALF PAD 9153649407 RP275050 manufactured by Popular Plastics.
[16087571]
Dealer reported that the end user was using an unknown wheelchair after having ankle surgery. User was riding on rough terrain when the footplate for the rp275050 hemi legrest split causing their foot to be dragged under the unit. And for the user to fall forward out of the chair. User went to the doctor, had x-rays, no broken bones, no alleged injury. User is in pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2015-00835 |
| MDR Report Key | 4489715 |
| Report Source | * |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-14 |
| Date of Event | 2015-01-13 |
| Date Facility Aware | 2015-01-14 |
| Report Date | 2015-02-05 |
| Date Reported to FDA | 2015-02-05 |
| Date Reported to Mfgr | 2015-02-05 |
| Date Added to Maude | 2015-02-06 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEVATING LEGREST W/ADJ CALF PAD 9153649407 |
| Generic Name | FOOTREST, WHEELCHAIR |
| Product Code | IMM |
| Date Received | 2015-02-06 |
| Model Number | RP275050 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POPULAR PLASTICS |
| Manufacturer Address | GUANGZHOU & DONGGUA CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-06 |