MAUDE Adverse Event Report: HANGZHOU FUYANG HONGWEI METAL PRODUCT CO. LTD DRIVE; ROLLATOR

Model Number 10257BL-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 03/20/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare received a report of an incident involving a rollator from an end user, who reported that while he was seated in the rollator, the "seat cracked and collapsed," causing him to fall and sustain a torn rotator cuff, as well as pain in his neck and shoulders.Drive is currently investigating the incident, including attempting to retrieve the product to evaluate it.Drive will update this filing if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT CO. LTD; liaoan village, wanshi town; fuyang district; hangzhou city, zhejiang 31140 6; CH 311406
• MDR Report Key: 15362924
• MDR Text Key: 299302219
• Report Number: 2438477-2022-00037
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 822383290331
• 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: 10257BL-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2022
• Distributor Facility Aware Date: 04/25/2022
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 122 KG