MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL DEVICE CO., LTD DRIVE; ROLLATOR

Model Number	R728RD
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.The unit was never returned for evaluation.The wheel broke off of the device while in use.The end-user fell and re-injured his hip.The incident caused a brief hospital stay and a stint in rehab for 5 days.Historical data for complaints of the same nature was reviewed and found to be very limited reporting with no trend.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL DEVICE CO., LTD; 1 chuangye st; sw industrial district; matou eco ind pk, handan city hebei 05604 6; CH 056046
• MDR Report Key: 10628074
• Report Number: 2438477-2018-00080
• Device Sequence Number: 3649383
• Product Code: ITJ
• UDI-Device Identifier: 00822383233253
• UDI-Public: 822383233253
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2020
• Report Date (Section F): 10/05/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: R728RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2018
• Event Location: Home
• Date Report to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Weight: 122
• Date Report Sent to FDA: 10/05/2020