MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-14 for HURRYCANE HCANE-BK-C2 manufactured by .
[49561190]
Drive devilbiss healthcare received a complaint regarding a broken hurrycane. Enduser was leaving her house and the top of the cane (handle) broke causing her to fall. Enduser suffered fractured pinky and hemorrhaged out of her nose. This report is based on information provided by the enduser's son. Product was evaluated and the claimed broken handle could not be confirmed. Device is fully functional.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2438477-2016-00031 |
MDR Report Key | 5795147 |
Date Received | 2016-07-14 |
Date of Report | 2016-06-09 |
Date Facility Aware | 2016-06-15 |
Report Date | 2016-07-15 |
Date Reported to FDA | 2016-07-15 |
Date Added to Maude | 2016-07-14 |
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 FAMILY MEMBER OR FRIEND |
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 | 2016-07-14 |
Model Number | HCANE-BK-C2 |
Device Availability | Y |
Device Age | 1 MO |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer Address | CH |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2016-07-14 |