MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,BASIC,STEEL,6",BLUE

Catalog Number MDS86850EBS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Injury (2348)

Event Date 04/04/2020

Event Type  Injury  

Manufacturer Narrative

It was reported by (b)(6), registered nurse, (b)(6), end users nurse, that the end-user had gotten up to use the bathroom in the middle of the night.End user reportedly stated she was using her "4 wheel walker" to ambulate in the hallway.Patient stated she got confused and thought it was her standard walker and she was lifting up and down without the brakes on.She went to put it down toward the floor and it rolled-out in front of her and she lost her balance".(b)(6) reports end-user fell to the floor where her son found her and called 911.The end user was transported to the emergency room via ambulance.X-rays taken that day ((b)(6) 2020), patient diagnosed with a right ankle fracture.End user discharged from the hospital on (b)(6) 2020, prescribed percocet 5/325 1-2 tabs every 4-6 hour prn for pain, physical therapy at home.The next md follow-up is scheduled the week of (b)(6) 2020.(b)(6) reports there is no sample to return, as this incident is a result of user error and there in nothing, wrong with the rollator.There is no further information at this time.Due to the reported incident and in an abundance of caution this medwatch is filed.If additional relevant information becomes available, a supplemental med watch will be filed.

Event Description

It was reported the end user was confused when she woke-up in the middle of the night and selected the incorrect device to ambulate to the bathroom.End user selected her rollator vs the walker and began to walk with the rollator by lifting the wheels off the ground and then returning them back to the ground without the brakes on.End user lost her balance, fell and broke her right ankle.

• Type of Device: ROLLATOR,BASIC,STEEL,6",BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10041607
• MDR Text Key: 190757468
• Report Number: 1417592-2020-00042
• 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,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850EBS
• Device Lot Number: 88517040036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 95