MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-24 for MULTI-PODUS SYSTEM 10-MP NA manufactured by Restorative Care Of America, Inc..
[150337]
The pt was ambulating to bathroom wearing the multi-podus boot system. They fell to the bathroom floor. They offered complaints of pain in right hip. X-ray revealed right femoral neck fracture. Pt states they tripped over their shoes. On 8/1/2000, the occupational therapist initiated a complaint of defective multi-podus boots. The brown rubber walker-bottom that attaches to the splint with velcro was detaching from sole. The correlation of the defective boot and the adverse event was made.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 296756 |
| MDR Report Key | 296756 |
| Date Received | 2000-08-24 |
| Date of Report | 2000-08-24 |
| Date of Event | 2000-07-25 |
| Date Facility Aware | 2000-08-01 |
| Report Date | 2000-08-24 |
| Date Reported to Mfgr | 2000-08-29 |
| Date Added to Maude | 2000-09-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI-PODUS SYSTEM |
| Generic Name | PROSTHETIC DEVICE FOR FOOT |
| Product Code | ISH |
| Date Received | 2000-08-24 |
| Model Number | 10-MP |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | US PATENT #5,269,748 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 287254 |
| Manufacturer | RESTORATIVE CARE OF AMERICA, INC. |
| Manufacturer Address | 11236 47TH ST NORTH CLEARWATER FL 33762 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-08-24 |