MAUDE Adverse Event Report: ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD DRIVE; WALKER

Model Number 10210-1

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Neck Pain (2433)

Event Date 04/26/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare received a complaint involving a walker from an end user, who reported that while recovering from spinal surgery, he was "using the walker when the back right leg bent and collapsed and hurt his neck and his back and will be seeking medical attention at his next doctor's appointment." drive has attempted to contact the end user to gather additional information and retrieve the product for evaluation, but there has been no response.Drive will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: WALKER
• Manufacturer (Section D): ZHONGSHAN BLISS MEDICAL INSTRUMENT CO., LTD; 98, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 15363253
• MDR Text Key: 299303779
• Report Number: 2438477-2022-00054
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383117379
• UDI-Public: 822383117379
• 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
• Type of Report: Initial
• Report Date: 09/06/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 10210-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2022
• Distributor Facility Aware Date: 04/26/2022
• Event Location: Home
• Date Report to Manufacturer: 09/09/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 82 KG