MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MDS86845BM

Catalog Number MDS86845BM

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that while end-user was standing up from sitting on the rollator, the left brake did not hold resulting in the rollator spinning and end-user falling onto her left side.The end-user reportedly potentially sustained a fracture to her back and is currently staying in a post-traumatic rehabilitation center.At the time of the incident, the end user reportedly ensured that the brakes were activated prior to standing up.The end-user was reportedly taken to the emergency department where x-rays and ultrasound of her back, legs and hips were done.Reportedly, "there may have been a fracture" to the end users back and end-user was referred to see an orthopedic specialist.The end-user was reportedly discharged from the emergency department the same day.On follow up with the event reporter, it was stated that the above-referred appointment with an orthopedic specialist did not occur yet due to the imaging disc remaining unavailable for review.It was reported that end-user is now staying in a post-traumatic rehabilitation center.It was denied that any medical treatment or further diagnostic exams were conducted related to the possible back fracture.Despite good faith efforts to obtain additional information, no further details related to the event are available.Due to the reported potential back fracture and the need for post-traumatic rehabilitation, this medwatch is being filed.The sample has not been returned for evaluation.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that while end-user was standing up from sitting on the rollator, the left brake did not hold resulting in the rollator spinning and end-user falling onto her left side.The end-user reportedly potentially sustained a fracture to her back and is currently staying in a post-traumatic rehabilitation center.

• Type of Device: MDS86845BM
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8897344
• MDR Text Key: 162646180
• Report Number: 1417592-2019-00136
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/15/2019

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: Health Professional
• Device Catalogue Number: MDS86845BM
• Device Lot Number: 86718120002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/15/2019
• 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): Other; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 75