MAUDE Adverse Event Report: NINGBO LIMITED METAL PRODUCTS CO HURRYCANE; WALKING CANE

Model Number 04297-3-R

Device Problem Unintended Collision (1429)

Patient Problems Death (1802); Fall (1848); Head Injury (1879); Intracranial Hemorrhage (1891)

Event Date 05/10/2013

Event Type  Death  

Event Description

(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.

• Brand Name: HURRYCANE
• Type of Device: WALKING CANE
• Manufacturer (Section D): NINGBO LIMITED METAL PRODUCTS CO
• Manufacturer (Section G): ZOOMWORKS LLC; 110 cheshire ln ste 200; hopkins MN 55305 000
• Manufacturer Contact: 110 cheshire ln ste 200; hopkins, MN 55305-0000
• MDR Report Key: 4575358
• MDR Text Key: 5474548
• Report Number: 3009198231-2014-00001
• Device Sequence Number: 1
• Product Code: KHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 04297-3-R
• Device Lot Number: 1140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2014
• Device Age: 5 MO
• Event Location: Home
• Date Report to Manufacturer: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR