MAUDE Adverse Event Report: UNKNOWN MECHANICAL WALKER (WHEELS & NO WHEELS); ROLLATOR

Model Number NA:SELFCARE

Device Problem Mechanical Problem (1384)

Patient Problem Damage to Ligament(s) (1952)

Event Type  Injury  

Manufacturer Narrative

At this time, it is unclear what, if any malfunction occurred with the rollator.Invacare is attempting to have the device returned for evaluation, but has not received it as of yet.The model and date code were requested but not able to be provided.It was reported there was an invacare sticker on the device.This rollator has multiple possible manufacturers, so the manufacturer of this device is currently unknown, the report will be filed to (b)(4).Should additional information become available, a supplemental record will be filed.The owner¿s manual for invacare rollators provides safety and warning instruction¿s including: warning: each individual should always consult with their physician or therapist to determine proper adjustment and usage.A physical/ occupational therapist should assist in the height adjustment of the rollator for maximum support and correct brake activation.When using the rollator in a stationary position, the hand brakes must be locked.Care and maintenance: verify operation of the brakes and have them adjusted if necessary.Contact your invacare dealer for brake adjustment.Inspect wheels periodically for wear or damage.Replace any broken, damaged or worn items immediately.Using the rollator: note: ensure the locking mechanism is fully engaged.

Event Description

The end users husband alleged that his wife reached for the rollator when getting up from the couch.The rollator moved due to the brakes not holding causing her to lose her balance and fall with the rollator.As a result of the fall, the brake had broken off and one of the wheels is messed up/damaged.His wife went to the er.She was not admitted.There were no broken bones, but they were told she has a torn ligament and was given a brace to wear on her leg.She is currently attending physical therapy.

• Brand Name: MECHANICAL WALKER (WHEELS & NO WHEELS)
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• Manufacturer (Section G): UNKNOWN
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 13667168
• MDR Text Key: 286575252
• Report Number: 1525712-2022-00002
• 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
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2022

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: NA:SELFCARE
• Device Catalogue Number: SELFCARE
• Device Lot Number: NOT AVAILABLE
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female