MAUDE Adverse Event Report: ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. HUGO / AMG; ROLLATOR

Model Number	700-957
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Device is a rollator which was distributed at the time of manufacture by amg medical in canada.We have not received the unit back for evaluation.The unit was manufactured in 2014.End-user was getting off the rollator to sit on a chair.She used one side of the rollator to support herself.She shifted her weight to the chair.The device's leg broke and she fell cutting her leg on the device.She injury would not stop bleeding.She required 6 stitches.She had a x-ray taken in er to confirm no metal was lodged in her leg.

• Brand Name: HUGO / AMG
• Common Device Name: ROLLATOR
• Manufacturer (Section D): ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.; 3 shenghui south road; nantou town; zongshan city, guangdong ; CH
• MDR Report Key: 11388687
• Report Number: 2438477-2021-00000
• Device Sequence Number: 14455626
• Product Code: ITJ
• UDI-Device Identifier: 00754021210022
• UDI-Public: 754021210022
• 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): 05/26/2021
• Report Date (Section F): 02/26/2021

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: 700-957
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/11/2021
• Device Age: 7 YR
• Event Location: Home
• Date Report to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2021
• 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
• Date Report Sent to FDA: 02/26/2021