MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL ROSCOE MEDICAL; TRANSPORT ROLLATOR

Model Number 30194

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2023

Event Type  Injury  

Event Description

Please be advised that my office has been retained by to represent her as it relates to injuries she suffered as a result of a product defect related to a roscoe transport rollator purchased at main medical supply located at.The product was pre-assembled when it was purchased.Was seriously injured while properly using the product.Unfortunately, the roscoe transport rollator collapsed as was being pushed by.

Event Description

Was rollator new/used? was it fully assembled by main medical supply at time of purchase? their website shows that have multiple rollators and some are assembled in their showroom.I believe it was new and was purchased fully assembled.Was the seat on rollator involved in this ancient on the unit at the time of purchase? she was sitting on the seat when it collapsed.Serial number provided.

Event Description

Update received 04/03/2024: 8.On or about (b)(6) 2023, '*she* fell at her insurance company's office because of a defective transport rollator that was purchased at main medical.17.As the proximate result of the negligence of defendants, roscoe and/or compass, and/or main medical, she sustained injuries and damages as follows: a.Severe and permanent injuries; b.Great pain and suffering, both physical and emotional, and loss of ability to perform usual functions and the injuries will cause further pain and suffering and loss of ability to perform usual functions in the future; and c.Reasonable and necessary medical expenses in and amount not yet determined, as well as further medical expenses to be incurred in the future.

• Brand Name: ROSCOE MEDICAL
• Type of Device: TRANSPORT ROLLATOR
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL; no. 1, chuangye street, southw; matou ecological industry park; handan city hebei, cn 05604 6; CH 056046
• MDR Report Key: 17037136
• MDR Text Key: 316300476
• Report Number: 3012316249-2023-00015
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 30194
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2023
• Distributor Facility Aware Date: 06/29/2023
• Device Age: 102 MO
• Date Report to Manufacturer: 06/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female