MAUDE Adverse Event Report: GENTEEL HOMECARE PRODUCTS ROLLITE ROLLATOR; WALKER, MECHANICAL

Model Number 65100

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

At this time, the underlying cause of the alleged issue is undetermined.The end user weighs 233 pounds, which is below the rollator's weight capacity of 300 pounds.The prison provided the rollator to the end user.Its previous use and maintenance history is unknown.The rollator was manufactured in november 2015, making it 6 years old at the time of the event.The assembly, installation and operating instructions state, "make sure that all hardware is secure, attachments are securely tighten and locked in the open position, and that casters and moving objects are in good working order before using this or any mobility aid." the care and maintenance section advises, "inspect wheels periodically for wear and damage.Replace any broken, damaged or worn items immediately.Periodically inspect the casters and caster stems for tightness and verify that the wheels are free of hair, lint and other debris that could interfere with free wheel operation." the end user stated that the prison's cameras caught video footage of the incident, which could be provided.A response letter was mailed to the end user requesting the video footage, along with his medical records and the return of the rollator to invacare for evaluation.If additional information becomes available, a supplemental record will be filed.

Event Description

Invacare received a letter sent by an end user in prison stating that he was sitting on a 65100 rollator when the front right wheel broke, causing him to fall backwards onto the cement floor.He stated that he hurt the right side of his back, hip, and shoulder, and the big toe on his left foot.Other inmates helped him up from the floor, then he was taken to the medical department via wheelchair and given pain medication.

• Brand Name: ROLLITE ROLLATOR
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): GENTEEL HOMECARE PRODUCTS; liyu industry area; danzao, nanhai; foshan, guangdong 52821 6; CH 528216
• MDR Report Key: 13053672
• MDR Text Key: 285988215
• Report Number: 1531186-2021-00005
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2021,11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 65100
• Device Lot Number: GT151112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2021
• Distributor Facility Aware Date: 11/29/2021
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 12/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 106 KG