MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. DRIVE; CRUTCHES

Model Number	10402-8
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a pair of crutches by a provider, who stated that the "rubber tips have worn down" and stated that the end user slipped and fell.There was no report or evidence of illness, injury or medical treatment associated with the complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: CRUTCHES
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.61 & no.96, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 17140036
• Report Number: 2438477-2023-00066
• Device Sequence Number: 14467897
• Product Code: IPR
• UDI-Device Identifier: 10822383101573
• UDI-Public: 10822383101573
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2023
• Report Date (Section F): 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10402-8
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 06/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/15/2023