MAUDE Adverse Event Report: HUGO; WALKER

HUGO; WALKER

Model Number	700-959E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report to be timely and in an overabundance of caution.We fill submit a follow-up if additional information becomes available.While in use the rear wheel brake on the right side did not engage.He fell and sustained multiple abrasions.He went to the doctor for treatment.

Search Alerts/Recalls

1 Device was Involved in the Event
Brand Name	HUGO
Common Device Name	WALKER
MDR Report Key	12696911
Report Number	2438477-2021-00063
Device Sequence Number	3706551
Product Code	ITJ
UDI-Device Identifier	00754021210602
UDI-Public	754021210602
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)	10/21/2021
Report Date (Section F)	10/21/2021
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	700-959E
Was the Report Sent to FDA?	Yes
Distributor Facility Aware Date	10/01/2021
Device Age	1 YR
Initial Date Received by Manufacturer	Not provided
Initial Report FDA Received Date	10/26/2021
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N)	No
Usage of Device	N
Patient Sequence Number	1
Outcome Attributed to Adverse Event	Other;
Patient Age	66 YR
Patient Weight	88
Date Report Sent to FDA	10/21/2021