MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for HURRYCANE UNKNOWN manufactured by Unknown.
[80493244]
Drive devilbiss healthcare is the initial importer of this device. Drive was notified of the event by an attorney letter. We have minimal information regarding the event and outcome. Our post market surveillance associate is continuing to reach out for additional information as per their process. One of the feet on the bottom of the base of the cane came off while in use. The enduser fell and broke bones. The cane is branded hurrycane and has a bed bath & beyond sku of (b)(4). We await feedback from the lawyer with specifics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438477-2017-00061 |
| MDR Report Key | 6725987 |
| Date Received | 2017-07-19 |
| Date of Report | 2017-06-19 |
| Date of Event | 2017-01-18 |
| Date Facility Aware | 2017-06-19 |
| Report Date | 2017-07-19 |
| Date Reported to FDA | 2017-07-19 |
| Date Added to Maude | 2017-07-19 |
| 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 | ATTORNEY |
| 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 | 2017-07-19 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-07-19 |