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

Model Number 10257BL-1

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

Patient Problem Laceration(s) (1946)

Event Date 01/23/2018

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.We are filing this report in an over-abundance of caution due to an mdr regression analysis.Deice was not returned for evaluation as it was a customer use error.End-user was exiting an elevator when his food caught on the rug.He was holding the loop brake as he fell and he brake broke.He hit his head.He was taken to the hospital and received stitches.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): HANGZHOU FUYANG HONGWEI METAL PRODUCT; liaoan village,; wanshi town; fuyang district, hangzhou city zhejiang, 31140 6; CH 311406
• MDR Report Key: 10885151
• MDR Text Key: 217683956
• Report Number: 2438477-2018-00086
• 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: 11/23/2020,11/13/2020

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: 10257BL-1
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2020
• Distributor Facility Aware Date: 01/25/2018
• Device Age: 24 MO
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR
• Patient Weight: 113