MAUDE Adverse Event Report: UNKNOWN HURRYCANE

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 09/17/2019

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a cane.Consumer was traveling from the bedroom foyer into the family room.He stepped on the base of the cane and lifted the cane.He fell.The cane was under him strung in three sections.He had contusions and was bleeding.He was taken to the er on doctor's orders.He was admitted to the hospital.He was discharged 2-3 days later diagnosed with e hematoma.

• Brand Name: HURRYCANE
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9253051
• MDR Text Key: 176296992
• Report Number: 2438477-2019-00074
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2019
• Distributor Facility Aware Date: 09/29/2019
• Device Age: 2 YR
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 91