MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD AMERIMARK; ROLLATOR

Model Number AM171AM

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 07/23/2021

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.The device has not been retrieved for evaluation.We are filing this report in an overabundance of caution.We will file a follow-up id additional data becomes available.While in use the front wheel of the device broke off.The end-user fell.We have not received confirmation of injuries that her attorney labeled "life altering".User was recovering from hip replacement surgery.Her surgeon advised her that the hip replacement is fine.However she was experiencing neck and back pain, and may have broken her nose.

• Brand Name: AMERIMARK
• Type of Device: ROLLATOR
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO., LTD; west of tanjialing road; yuyao, zhejiang 31540 8; CH 315408
• MDR Report Key: 12422696
• MDR Text Key: 269807346
• Report Number: 2438477-2021-00039
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383548388
• UDI-Public: 822383548388
• 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: 09/03/2021,09/02/2021

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: AM171AM
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2021
• Distributor Facility Aware Date: 08/03/2021
• Device Age: 1 YR
• Date Report to Manufacturer: 09/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 45