MAUDE Adverse Event Report: DRIVE; ROLLATOR

DRIVE; ROLLATOR

Model Number	10233
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hip Fracture (2349)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator.The end user's spouse reported that "the front leg collapsed yesterday.My husband is now in the hospital with a hip fracture and is awaiting hip surgery." the report was in the form of a comment on an e-commerce website, and drive is therefore unable to contact the end user directly to arrange for inspection of the unit or obtain further information regarding the incident.Drive will file an update to this report if additional information becomes available.

Search Alerts/Recalls

1 Device was Involved in the Event
Brand Name	DRIVE
Common Device Name	ROLLATOR
MDR Report Key	14948531
Report Number	2438477-2022-00040
Device Sequence Number	4763516
Product Code	ITJ
UDI-Device Identifier	00822383118550
UDI-Public	822383118550
Combination Product (Y/N)	N
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)	07/07/2022
Report Date (Section F)	07/07/2022
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	10233
Was Device Available for Evaluation?	No
Was the Report Sent to FDA?	Yes
Distributor Facility Aware Date	02/22/2022
Initial Date Received by Manufacturer	Not provided
Initial Report FDA Received Date	07/07/2022
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; Required Intervention;
Patient Sex	Male
Patient Weight	109 KG
Date Report Sent to FDA	07/07/2022