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

Model Number 700-957

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 01/28/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 242638257
• Report Number: 2438477-2021-00000
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00754021210022
• UDI-Public: 754021210022
• 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: 02/26/2021,05/26/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 700-957
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2021
• Distributor Facility Aware Date: 02/11/2021
• Device Age: 7 YR
• Event Location: Home
• Date Report to Manufacturer: 03/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization