MAUDE Adverse Event Report:; ROLLATOR,BASIC,BURGUNDY

Catalog Number MDS86850E

Device Problem Break (1069)

Patient Problems Headache (1880); Concussion (2192)

Event Date 08/15/2021

Event Type  Injury  

Manufacturer Narrative

It was reported; while sitting on the rollator the left front wheel broke and the end user fell and hit her head.Phone call place to (b)(6), end user.This clinician spoke with both end user and visiting nurse ((b)(6)) whom reported the incident.End user reports she was outside sitting on the rollator (stationary) on her cement patio visiting with friends and family when suddenly the left front wheel broke off.End user reports, "she fell to her left side striking the left side of her head first and then falling on to her left side." end user states, she was in extreme pain.End user reports her daughter drove her to (b)(6) hospital in (b)(6) where an mri was taken and she was released later that day.End user reports, her primary care provider later told her that she has/had a concussion.End user reports, she continues to have migraine headaches and has a follow-up appointment with her physician the first week of (b)(6) 2021.End user reports, the rollator is approximately 4 years old, and purchased through her insurance.On 8/30/2021 additional information received by (b)(6).Photos and model number of rollator received.End user reports the sample is available for return and evaluation however, at the time of this report the sample has not been returned/received for evaluation.Due to the reported incident, medical intervention and in an abundance of caution, a med watch is being filed.If any further relevant information is identified or obtained, a supplemental med watch will be submitted.

Event Description

It was reported; while sitting on the rollator the left front wheel broke and the end user fell and hit her head.Patient reports as a result she had/has a concussion and migraine headaches.

Event Description

It was reported; while sitting on the rollator the left front wheel broke and the end user fell and hit her head.Patient reports as a result she had/has a concussion and migraine headaches.

Manufacturer Narrative

Supplemental documentation changed/additional information added.D9 device available for evaluation -yes, returned (b)(6) 2021.G6 type of report - follow-up, 01.H2 if follow-up what type? additional information, device evaluation.H3 device evaluated by manufacturer -evaluation summary attached.H6 type of investigation- h5 investigation conclusion zcd00007/not a product defect.H10 investigation report reads as follows: 09/16/2021 11:25:12 cst (brallo)."material number: mds86850e sample and/or photo provided? sample (quantity provided: 1 - ea).Lot number? 88517070010.Defect(s) from complaint: 1.Investigation results: confirmed.Investigation conclusion / root cause: "we received 1 ea rollator with the item number of mds86850e with the lot number of 88517070010 in used condition.Inspected the brakes and they seemed to be slightly out of adjustment.When the brake was set, the rear wheels would continue to rotate.The backrest attaches and detaches without any issues.The seat upholstery appears to be in used condition with a few scratches and stains present.Duct tape was holding the top portion of the seat together because there was a tear.The frame itself has a few minor scratches and dents present, which are likely to be caused by impact.All four wheels are covered with a significant amount of dirt grime and hair.All of the adjustment knobs are tight and secure.Based on the condition of the rollator it is undetermined what type of maintenance has been performed.The customer is stating that the "wheel fell off while they were sitting on the rollator." upon further investigation of the sample, it was discovered that the roll pin for the right front wheel was missing.The caster stem and the threaded caster stem insert does not appear to be stripped.It is likely that after the roll pin fell out the caster stem unthreaded itself over time.Which in return caused the wheel to fall off.Based on the evidence provided with the physical sample, and with the comments listed in the complaint.A potential root cause of this issue is unknown.However, given the age, and condition of the unit, failure to perform routine maintenance could be a contributor to a potential root cause of this issue.The customer complaint has been confirmed.The division will monitor through quarterly trending.".

• Type of Device: ROLLATOR,BASIC,BURGUNDY
• MDR Report Key: 12435784
• MDR Text Key: 270265223
• Report Number: 1417592-2021-00170
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 83