MAUDE Adverse Event Report: CAREMAX REHABILITATION EQUIPMENT CO., LTD. MEDICHOICE; CRUTCH

Model Number 77708A

Device Problem Disassembly (1168)

Patient Problem Fall (1848)

Event Date 09/24/2015

Event Type  malfunction  

Event Description

Owens & minor distribution, inc., the initial importer and private-label distributor of the medichoice crutch, received a product problem report from a user facility.The user facility reported that the wing nut on one crutch provided to one of their patients came loose on the hand grip causing the patient to fall.The fall occurred away from the user facility.The patient was examined at the hospital where they received the crutch.No injury occurred as a result of the fall, and no medical intervention was required to prevent permanent impairment or damage.

• Brand Name: MEDICHOICE
• Type of Device: CRUTCH
• Manufacturer (Section D): CAREMAX REHABILITATION EQUIPMENT CO., LTD.; shugang dadao, pingzhou town; nanhai area, foshan city; foshan city, guangdong, china ; CH
• MDR Report Key: 5439070
• MDR Text Key: 38286255
• Report Number: 3003753847-2016-00001
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 77708A
• Device Catalogue Number: 77708A
• Device Lot Number: CM1502 037576
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2016
• Distributor Facility Aware Date: 01/25/2016
• Event Location: Home
• Date Report to Manufacturer: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 68