MAUDE Adverse Event Report: ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD DRIVE; WALKER

Model Number 10220HD

Device Problem Break (1069)

Patient Problems Abrasion (1689); Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a walker by a provider who stated that "the front right leg broke on the walker causing the end user to hit his face/head onto a steel chair." the end user sustained injuries of peeled skin near his left eye, cut on the back of his ear, as well as a sore nose and jaw.Upon follow-up with the end user, he stated that "the medics arrived to his house and suggested to perform stitches on his ear but he refused.The end user was then reportedly prescribed antibiotics to prevent an infection of his cuts drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD; no 4 and no 8 plants 9 shenghu; south road nantou town; zhongshan city, guangdong 51000 0; CH 510000
• MDR Report Key: 16061698
• MDR Text Key: 306270763
• Report Number: 2438477-2022-00133
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10220HD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2022
• Distributor Facility Aware Date: 11/28/2022
• Device Age: 5 YR
• Date Report to Manufacturer: 01/04/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male