MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 100RA

Catalog Number 100RA

Device Problem Material Twisted/Bent (2981)

Patient Problem Loss of consciousness (2418)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that while end user was in the kitchen to wash dishes, end user locked the rollator in place and end user sat down on the rollator to proceed washing the dishes.Reportedly, the end user went to turn around towards the refrigerator when the rollator's wheel bent and snapped inward resulting in the end user falling out of the rollator, hitting head on the refrigerator.The end user reportedly lost consciousness and went to the emergency room the following day for evaluation.It was added that end user followed up with primary care physician the following weekend.Per report, the end- user had another "blackout episode, possibly from incident" and end-user was admitted to the hospital (b)(6) 2019.Ct scan & mri were reportedly done.No results were reported.It was added that no treatment was required for the patient and patient stayed in the hospital for "rest, medication, and daily analysis and monitoring.Head, heart, kidney & blood pressure treatment." the end user is reportedly currently doing outpatient physical therapy and shock therapy.Due to the reported incident and the related hospitalization, this medwatch is being filed.The sample has not been returned for evaluation.Pictures of the rollator were submitted.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 seating on the rollator, the leg/wheel bent inwards resulting in end user falling and hitting head.End-user required hospitalization.

• Type of Device: 100RA
• 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: 9186116
• MDR Text Key: 170109005
• Report Number: 1417592-2019-00178
• 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: 10/14/2019

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: Lay User/Patient
• Device Catalogue Number: 100RA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/14/2019
• 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): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 102