MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-13 for DRIVE MEDICAL UNKNOWN manufactured by Unknown.
[57398490]
While walking fast on an uneven surface, patient tripped over her cane and fell down bruising her elbows and knees. The ambulance arrived on scene and patient refused to go to hospital. After a while her legs swelled due to cellulitis. Patient was then hospitalized for 3 weeks. Unsure if event caused cellulitis. Cane was allegedly drive product however no information was provided to confirm that it is drive product. Drive is unable to identify the product and manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2016-00048 |
| MDR Report Key | 6028308 |
| Date Received | 2016-10-13 |
| Date of Report | 2016-10-13 |
| Date of Event | 2016-06-21 |
| Date Added to Maude | 2016-10-13 |
| 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 | PATIENT |
| 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 | 3 |
| Brand Name | DRIVE MEDICAL |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2016-10-13 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | UNKNOWN UNKNOWN UNKNOWN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-10-13 |