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

Model Number R728RD

Device Problem Material Fragmentation (1261)

Patient Problem Pain (1994)

Event Date 02/23/2018

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.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
• Type of Device: 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
• MDR Text Key: 209832187
• Report Number: 2438477-2018-00080
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233253
• UDI-Public: 822383233253
• 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: 10/05/2020,10/02/2020

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: R728RD
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2020
• Distributor Facility Aware Date: 04/12/2018
• Event Location: Home
• Date Report to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2020
• 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: 61 YR
• Patient Weight: 122