MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD HURRYWIORKS; CANE

Model Number HURRYCANE

Device Problem Scratched Material (3020)

Patient Problem Laceration(s) (1946)

Event Date 09/28/2021

Event Type  Injury  

Event Description

From drive devilbiss: 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): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer (Section G): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west; district, no. 6 workshop ii; zhongshan city, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 13650160
• MDR Text Key: 286424941
• Report Number: 3014644996-2022-00008
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2022

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 Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female