MAUDE Adverse Event Report: REBORN MEDICAL CO., LTD. DRIVE MEDICAL; MECHANICAL WALKER

Model Number 10210-1

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Unspecified Infection (1930)

Event Date 06/24/2017

Event Type  Injury  

Event Description

Drive devilbiss healthcare received a notification of an incident involving a walker that drive imports and distributes.The patient was using the walker when allegedly she lost balance and the walker fell on top of her.The patient suffered a cut on her right leg which eventually became infected.She is required to take antibiotics and undergo laser therapy.

• Brand Name: DRIVE MEDICAL
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): REBORN MEDICAL CO., LTD.; guangfeng wei, yumin village; dongsheng county; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 6792613
• MDR Text Key: 82632027
• Report Number: 2438477-2017-00066
• 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: Patient
• Type of Report: Initial
• Report Date: 08/17/2017,07/18/2017

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
• Device Operator: No Information
• Device Model Number: 10210-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2017
• Distributor Facility Aware Date: 07/20/2017
• Event Location: Home
• Date Report to Manufacturer: 08/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Other
• Patient Age: 81 YR
• Patient Weight: 52