MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-07-02 for HURRYCANE 04297-3-R manufactured by Ningbo Limited Metal Products Co.
[5474548]
(b)(6) purchased a hurrycane as a gift for his father, (b)(6). The son, (b)(6), lives in (b)(6) and his father lives in (b)(6). (b)(6), the son, was not present as time of incident. (b)(6) reported that his father, (b)(6), had just gotten home from 2 weeks of rehab after having had a pacemaker operating and his father has been home for 5 to 6 days. (b)(6) reported that his father normally used a walker but was trying to get used to a cane. (b)(6) fell and hit his head on the carpeted floor. No one witnessed the fall. His wife came in to help him and later guessed that he caught the cane on the edge of his wife's recliner/rocker. They allege that when he lifted it up it unfolded and his father fell and hit his head on the carpeted floor. He is reported to have suffered from a brain bleed which caused his death a few hours later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009198231-2014-00001 |
| MDR Report Key | 4575358 |
| Report Source | 99 |
| Date Received | 2014-07-02 |
| Date of Report | 2014-06-17 |
| Date of Event | 2013-05-10 |
| Date Facility Aware | 2014-06-03 |
| Report Date | 2014-06-17 |
| Date Reported to Mfgr | 2014-06-03 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2015-03-09 |
| 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 |
| Manufacturer Street | 110 CHESHIRE LN STE 200 |
| Manufacturer City | HOPKINS MN 553050000 |
| Manufacturer Country | US |
| Manufacturer Postal | 553050000 |
| Manufacturer G1 | ZOOMWORKS LLC |
| Manufacturer Street | 110 CHESHIRE LN STE 200 |
| Manufacturer City | HOPKINS MN 55305000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55305 0000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HURRYCANE |
| Generic Name | WALKING CANE |
| Product Code | KHY |
| Date Received | 2014-07-02 |
| Model Number | 04297-3-R |
| Lot Number | 1140 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NINGBO LIMITED METAL PRODUCTS CO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-07-02 |