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

Model Number 77710A

Device Problem Disassembly (1168)

Patient Problem Fall (1848)

Event Date 11/12/2017

Event Type  malfunction  

Event Description

(b)(4) is the initial importer and private-label distributor of the medichoice aluminum crutch, 131477710a.A product related problem was reported to an (b)(4) employee on november 14th, 2016.The (b)(4) employee reported that the patient entered the er with left knee pain on (b)(6) 2016.The patient reported that he could not put weight on his knee.He was discharged from the er with medichoice aluminum crutches.The patient stated that while he was walking to his car, he fell and twisted his knee.The crutch also broke during the incident-- it is not clear from the report whether the crutch broke, leading to the fall or whether the fall caused the crutch to break.The patient returned to the er with the broken crutch but was nor formally re-admitted.The patient stated he refused re-assessment and was provided with a new set of crutches.No new injury was reported nor was medical intervention required to prevent permanent impairment or damage to the patient.

• Brand Name: MEDICHOICE
• Type of Device: ALUMINUM CRUTCH
• Manufacturer (Section D): CAREMAX REHABILITATION EQUIPMENT CO., LTD; pingnan industrial area, shuga; pingzhou town, nanhai area; foshan city, guangdong 52851 2; CH 528512
• Manufacturer (Section G): CAREMAX REHABILITATION EQUIPMENT CO., LTD; pingnan industrial area, shuga; pingzhou town, nanhai area; foshan city, guangdong 52851 2; CH 528512
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 6255131
• MDR Text Key: 65361206
• Report Number: 3005555653-2017-00001
• 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: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 77710A
• Device Catalogue Number: 131477710A
• Device Lot Number: 1607CA01A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2016
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 120