MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; FALL PREVENTION KIT WITH LOGO

Catalog Number	DYKF1045
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by facility representative, clinical project manager, osf healthcare saint francis medical center, with additional information related to this incident.Reporter states a gait belt clasp broke while assisting an (b)(6) male patient from his bed to a chair.Reporter states, "the patient reached forward slightly which is when the gait belt clasp broke" patient fell and may have hit his head.Reporter states, the facility followed "post fall procedure" and patient transported to the local emergency room.A cat scan was completed (the results are unknown).Reporter states, "patient was admitted as an inpatient at the time of the event for observation." date of discharge is unknown.Patient was discharged to his home.The sample has not been returned for evaluation.No further information is available at this time.Due to the nature of the reported incident and in abundance of caution, this medwatch is being filed.No further information is available at this time.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported a gait belt clasp broke while assisting patient from the bed to the chair.Patient fell and hit his head.Patient was admitted to the local hospital observation and cat scan was completed.
Event or Problem Description
It was reported a gait belt clasp broke while assisting patient from the bed to the chair.Patient fell and hit his head.Patient was admitted to the local hospital observation and cat scan was completed.
Additional Manufacturer Narrative
Changed/additional information added.G6 type of report: follow-up.H3 device evaluated by manufacturer: yes, evaluation summary attached.H10 investigation report reads as follows: (b)(6) 2020, "the reported issue of gait belt broke was confirmed.The root cause was due to a vendor product issue.Scar-00079 was issued to the vendor in regards to this issue.Trending shows one previous report of this issue for this kit within the past year, but the in the previous report a different gait belt was being used in the kit and there were no reports of a patient falling.Ok to close.".

• Common Device Name: FALL PREVENTION KIT WITH LOGO
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10771459
• Report Number: 1417592-2020-00107
• Device Sequence Number: 17174745
• Product Code: FMR
• UDI-Device Identifier: 10889942865062
• UDI-Public: 10889942865062
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYKF1045
• Device Lot Number: 20EBO0674A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 51