MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SAFE-T POLE,GUARDIAN, POLE ONLY

Catalog Number G98120P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 05/29/2019

Event Type  Death  

Manufacturer Narrative

It was reported that a male with history of a previous stroke, lewy body dementia, diabetes, coronary artery disease, and previous meningioma brain tumor was found lying on his left side on the floor deceased, with his neck between his bed and a guardian safe-t pole.The coroner's office reported that when deputies arrived on scene the deputies kicked loose the guardian safe-t pole to release the deceased from the current position, moved the decedent and assessed him.According to the coroner, the cause of death was listed as both natural causes (due to client's medical history) and accidental death.The coroner reported that the actual guardian safe-t pole involved in the reported incident is not available and will not be returned for evaluation.Despite multiple good faith efforts to obtain additional information, the customer contact was unwilling to provide further patient, product or incident details to the manufacturer at the time of this report.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that a deceased male was found lying on his left side on the floor with his neck between his bed and a guardian safe-t pole.

• Type of Device: SAFE-T POLE,GUARDIAN, POLE ONLY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8857332
• MDR Text Key: 153159391
• Report Number: 1417592-2019-00125
• Device Sequence Number: 1
• Product Code: IKX
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: G98120P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR