MAUDE Adverse Event Report: MAXHEALTH CORP. PROBASICS; TRANSPORT ROLLATOR

Model Number RLATBG

Device Problem Structural Problem (2506)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/22/2019

Event Type  Injury  

Event Description

The end-user alleges that the product collapsed on her second day of use and she fell fracturing her femur requiring open reduction with internal fixation.Per end-user counsel: plaintiff is slim (well under 250).The rollator did not break, there are no broken pieces, there was no manufacturing defect.Plaintiff was walking with it inside at her home and it closed up on her.He thinks that plaintiff picked it up from the store and believes that it was given to plaintiff fully assembled.Claiming design defect as it does not have a locking mechanism to prevent this type of incident.On 02/21/2020 chb was informed of incident.On 03/30/2020 chb was informed of injury.

• Brand Name: PROBASICS
• Type of Device: TRANSPORT ROLLATOR
• Manufacturer (Section D): MAXHEALTH CORP.; 14f, no. 99, section 1; xintai 5th road; xizhi district new taipei city, 22102 ; TW 22102
• MDR Report Key: 9947699
• MDR Text Key: 187304125
• Report Number: 3012316249-2020-00013
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00815067071814
• UDI-Public: (01)00815067071814(21)
• 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: 04/10/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RLATBG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2020
• Distributor Facility Aware Date: 02/21/2020
• Device Age: 22 MO
• Date Report to Manufacturer: 04/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization