MAUDE Adverse Event Report: UNKNOWN HURRYWIORKS; CANE

Model Number HURRYCANE

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 09/28/2021

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a cane.The user has advised that she will not return the device to us for evaluate.We will file a follow-up submission if additional information becomes available.We are filing this report in an overabundance of caution.The end user was leaning against her dresser while in bed as she reached for her cane.She wanted to exit the bed.She cut her hand on the "round holes" of the cane that were "very sharp." no information regarding medical attention was gathered.

• Brand Name: HURRYWIORKS
• Type of Device: CANE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12681699
• MDR Text Key: 277911234
• Report Number: 2438477-2021-00060
• Device Sequence Number: 1
• Product Code: IPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/21/2021,10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HURRYCANE
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2021
• Distributor Facility Aware Date: 09/28/2021
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1