MAUDE Adverse Event Report: HERO HEALTH, INC. HERO 100; DISPENSER, SOLID MEDICATION

Model Number	H100
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user reported that the hero smart dispenser double dosed them on their blood pressure medications.On (b)(6) 2023 it was additionally reported that due to the symptoms they've experienced, they were admitted to the emergency department for fluids, monitoring, labs.The user reported higher losartan levels than needed.The hero engineering team investigated the reported issue and could not confirm the customers claims, however on rare occasions it is possible that 2 pills are picked up together due to the hero smart dispenser design limitations.
Additional Manufacturer Narrative
The hero device should not be used by a recipient of medication who is incapable of verifying the accuracy of each dispensed dose (such as those suffering from dementia or other cognitive or physical impairments) unless pill dispense accuracy is being verified, in each instance, by qualified person(s) trusted by the medication recipient, i.E.A caregiver, a healthcare aide, and/or a healthcare professional.The medication recipient (or a trusted qualified person) must always verify that the types of pills and number of pills dispensed by the hero device match the prescribed or desired dosage before ingesting the contents of the pill cup.The hero device should not be used to dispense medicines that have high dosage sensitivity, that have a narrow therapeutic window, that are used to treat acute conditions or that are used to treat life-threatening events.Even though the hero device is capable of successfully and accurately dispensing most whole pills loaded into the device on most occasions, hero cannot guarantee the accuracy of medication dispensed during every dispense cycle due to the potential for human error and/or mechanical and software limitations or failures.The hero engineering team investigated the reported issue and could not confirm the customers claims, however on rare occasions it is possible that 2 pills are picked up together due to the hero smart dispenser design limitations.
Event or Problem Description
On (b)(6) 2023 the user reported that the hero smart dispenser double dosed them on their blood pressure medications.On (b)(6) 2023 it was additionally reported that due to the symptoms they've experienced, they were admitted to the emergency department for for fluids, monitoring, labs.The user reported higher losartan levels than needed.The hero engineering team investigated the reported issue and could not confirm the customers claims, however on rare occasions it is possible that 2 pills are picked up together due to the hero smart dispenser design limitations.
Additional Manufacturer Narrative
The hero device should not be used by a recipient of medication who is incapable of verifying the accuracy of each dispensed dose (such as those suffering from dementia or other cognitive or physical impairments) unless pill dispense accuracy is being verified, in each instance, by qualified person(s) trusted by the medication recipient, i.E.A caregiver, a healthcare aide, and/or a healthcare professional.The medication recipient (or a trusted qualified person) must always verify that the types of pills and number of pills dispensed by the hero device match the prescribed or desired dosage before ingesting the contents of the pill cup.The hero device should not be used to dispense medicines that have high dosage sensitivity, that have a narrow therapeutic window, that are used to treat acute conditions or that are used to treat life-threatening events.Even though the hero device is capable of successfully and accurately dispensing most whole pills loaded into the device on most occasions, hero cannot guarantee the accuracy of medication dispensed during every dispense cycle due to the potential for human error and/or mechanical and software limitations or failures.The root cause of the reported incident cannot be confirmed conclusively, as the issue could not be reproduced in the returned device.The device passed all functional tests.

• Brand Name: HERO 100
• Common Device Name: DISPENSER, SOLID MEDICATION
• Manufacturer (Section D): HERO HEALTH, INC.; 90 broad street; new york NY 10004
• Manufacturer (Section G): HERO HEALTH, INC.; 90 broad street; new york NY 10004
• Manufacturer Contact: frederick tobia ; 90 broad street; new york, NY 10004 ; 8558559962
• MDR Report Key: 18147888
• Report Number: 3014660737-2023-69435
• Device Sequence Number: 6564593
• Product Code: NXB
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: H100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOSARTAN POTASSIUM 50MG; LOSARTAN POTASSIUM 50MG
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown