MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-12 for HURRYCANE UNKNOWN manufactured by Unknown.
[126929429]
Drive devilbiss healthcare is the initial importer of the device which is a cane branded hurrycane. We have received notification of the incident from the end-user's attorney. We have little information and no access to the device. In an overabundance of caution we are filing this mdr. We intend to update this filing once additional information is available. The attorney has reported that the cane - model unknown- has allegedly failed causing the end-user to fall and fracture her femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2018-00058 |
| MDR Report Key | 8059279 |
| Date Received | 2018-11-12 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-01-03 |
| Date Facility Aware | 2018-10-16 |
| Report Date | 2018-11-12 |
| Date Reported to FDA | 2018-11-12 |
| Date Added to Maude | 2018-11-12 |
| 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 |
| 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 | HURRYCANE |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2018-11-12 |
| Model Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-12 |