MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for HURRYCANE UNKNOWN manufactured by Unknown.
[134895732]
Drive devilbiss healthcare is the initial importer of the device which is a hurrycane branded cane. Drive became aware of the incident through a legal summons withdrawing permission to obtain medical records or statements for our investigation. We are filing this report in an overabundance of caution. Our claims department will provide required data sets as they become available. The end-user sustained injuries from a slip and fall incident while using a cane reportedly branded hurrycane. The cane handle reportedly snapped. She fell and fractured her ankle resulting in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2018-00056 |
| MDR Report Key | 8301898 |
| Date Received | 2019-02-04 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-04-28 |
| Date Facility Aware | 2018-09-28 |
| Report Date | 2018-11-12 |
| Date Reported to FDA | 2018-11-12 |
| Date Added to Maude | 2019-02-04 |
| 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 | 2019-02-04 |
| 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 | 2019-02-04 |