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

Model Number	MOB1014BLK
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CRUTCH
• Manufacturer (Section D): CAREMAX REHABILITATION EQUIPMENT CO., LTD.
• MDR Report Key: 8949605
• Report Number: MW5089457
• Device Sequence Number: 2042260
• Product Code: IPR
• UDI-Device Identifier: 00818323027198
• UDI-Public: 00818323027198
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: MOB1014BLK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1