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

Model Number 131477710A

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 03/15/2023

Event Type  Injury  

Manufacturer Narrative

The product involved in the event is available to be returned.A follow-up report will be provided upon conclusion of investigation.Owens & minor distribution inc.Home-office is the initial importer of this device.A supplier corrective action (scar) has been issued to the supplier to investigate this incident and advise on any corrective actions taken.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or has caused serious injury.

Event Description

Reporter indicated that they had surgery on (b)(6) 2023.They were provided medichoice aluminum crutches, serial number (b)(6).The reporter is the patient who is 6"2' and 260lbs.The customer indicated they were the perfect fit.The rubber tip of one of the crutches broke during use and they fell, taking multiple hits to their back, head, and ankle they had surgery on.

Manufacturer Narrative

A device history record (dhr) of the production batch records was reviewed and no defective rubber tips were recorded.Inspection of the retention samples found no mechanical failure or quality issue.From the examination of the sample received, it was determined that this was an isolated incident.In addition, the reported incident has been entered in our tracking and trending program in order to continuously monitor for emerging trends in the marketplace.Owens & minor distribution inc.Home-office is the initial importer of this device.A supplier corrective action (scar) has been issued to the supplier to investigate this incident and advise on any corrective actions taken.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or has caused serious injury.

• Brand Name: MEDICHOICE
• Type of Device: MEDICHOICE CRUTCHES ALUMINUM TALL
• Manufacturer (Section D): CAREMAX REHABILITATION EQUIPMENT CO., LTD; pingnan industrial area; shugang dada, pingz, nanhai, f; guangdong, china 52851 2; CH 528512
• Manufacturer (Section G): CAREMAX REHABILITATION EQUIPMENT CO., LTD; pingnan industrial area; shugang dadao; guangdong, china 52851 2; CH 528512
• Manufacturer Contact: brendan daniels ; 9120 lockwood blvd.; mechanicsville, VA 23116
• MDR Report Key: 16994479
• MDR Text Key: 315866478
• Report Number: 3003753847-2023-00001
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023,06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 131477710A
• Device Catalogue Number: 131477710A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/26/2023
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 05/08/2023
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 118 KG