MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-01 for EZ ACCESS TRIFOLD RAMP ADVANTAGE SERIES, 10 FT, 800# CAPACITY 100 FOOT TRIFOLD 6020 manufactured by Express Ramps.
[20413097]
Quadriplegic in power wheelchair used a 10 ft trifold advantage-trifold10as portable access ramp and drove the wheelchair over the side of the ramp. The lip for guidance isn't strong/tall enough for power wheelchair. Since quadriplegic, uses chin for steering. Fell once foot to ground with a (b)(6) wheelchair. Required a visit to emergency room and shoulder x-ray showing chip in left shoulder. The ramp has a 800# capacity and looks bent. Dates of use: (b)(6) 2010 - (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022146 |
| MDR Report Key | 2241004 |
| Date Received | 2011-05-01 |
| Date of Report | 2011-05-01 |
| Date of Event | 2011-04-30 |
| 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 | 3 |
| 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 | EZ ACCESS TRIFOLD RAMP ADVANTAGE SERIES, 10 FT, 800# CAPACITY |
| Generic Name | PORTABLE RAMP |
| Product Code | KNO |
| Date Received | 2011-05-01 |
| Model Number | 100 FOOT TRIFOLD |
| Catalog Number | 6020 |
| ID Number | ITEM# 6020 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXPRESS RAMPS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-05-01 |