MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. DRIVE; ROLLATOR

Model Number 795B

Device Problem Mechanical Jam (2983)

Patient Problems Bruise/Contusion (1754); Fall (1848); Head Injury (1879)

Event Date 04/21/2020

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.We have not received the device for evaluation.The device caught on a crack in the sidewalk and stopped abruptly.The enduser fell and hit his head causing a bruise on the side of his head.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.; 3 shenghui south road; nantou town; zhongshan city,, guangdong ; CH
• Manufacturer (Section G): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.; 3 shenghui south road; nantou town; zhongshan city,, guangdong ; CH
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 10513219
• MDR Text Key: 206325233
• Report Number: 3004443928-2020-00001
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383213484
• UDI-Public: 822383213484
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2020

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: Lay User/Patient
• Device Model Number: 795B
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 79 YR
• Patient Weight: 61