MAUDE Adverse Event Report: CAREMAX REHABILITATION EQUIPMENT CO., LTD. VIVE FOREARM CRUTCHES

Model Number MOB1014BLK

Device Problems Break (1069); Collapse (1099)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Consumer left a comment stating, "i got these yesterday.Went out today and the one crutches collapsed on me, making me fall to the ground and injuring myself.The reason i got these is because my old ones did the same thing.These will be going back." fda safety report id# (b)(4).

• Brand Name: VIVE FOREARM CRUTCHES
• Type of Device: CRUTCH
• Manufacturer (Section D): CAREMAX REHABILITATION EQUIPMENT CO., LTD.
• MDR Report Key: 8949605
• MDR Text Key: 156275575
• Report Number: MW5089457
• Device Sequence Number: 1
• Product Code: IPR
• UDI-Device Identifier: 00818323027198
• UDI-Public: 00818323027198
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MOB1014BLK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1