MAUDE Adverse Event Report: DANYANG JUMAO DRIVE; CRUTCH

Model Number 10502-1

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

(b)(6) is the initial importer of the device which is a crutch.The consumer received the crutch from a hospital.He noticed that the bolt on the crutch was missing.When he used the crutch it snapped.He fell.He fractured his leg in two additional places.

• Brand Name: DRIVE
• Type of Device: CRUTCH
• Manufacturer (Section D): DANYANG JUMAO; 36 danyang rd; danyang city; jiangsu provence, jiangsu 21230 0; CH 212300
• MDR Report Key: 8516588
• MDR Text Key: 142039907
• Report Number: 2438477-2019-00021
• Device Sequence Number: 1
• Product Code: IPR
• UDI-Device Identifier: 00822383128609
• UDI-Public: 822383128609
• 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: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10502-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2019
• Distributor Facility Aware Date: 03/11/2019
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention