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

Model Number	H100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Confusion/ Disorientation (2553)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On 2/15 the customer reported that the hero smart unit dispensed 2 extra buspar medications and 1 extra cymbalta pill.It was reported that they were hospitalized due to the issue.On 2/17 the caregiver reached out and reported that the user developed arm tremors and their physician was concerned with the medications' interaction with each other (serotonin syndrome).It was also reported that on 2/14 around noon the user became disoriented with an altered mental status and was transported to the emergency room.As per the caregiver: "with other tests normal, the working theory was serotonin syndrome and they began to reduce her medication amounts.They recommended check in to the hospital".Upon further follow up the user was released and is doing fine.
Event or Problem Description
On (b)(6) 2023 the customer reported that the hero smart unit dispensed 2 extra buspar medications and 1 extra cymbalta pill.It was reported that they were hospitalized due to the issue.On (b)(6) 2023 the caregiver reached out and reported that the user developed arm tremors and their physician was concerned with the medications' interaction with each other (serotonin syndrome).It was also reported that on (b)(6) 2023 around noon the user became disoriented with an altered mental status and was transported to the emergency room.As per the caregiver: "with other tests normal, the working theory was serotonin syndrome and they began to reduce her medication amounts.They recommended check in to the hospital".Upon further follow up the user was released and is doing fine.
Additional Manufacturer Narrative
Inspection confirmed no device problems found.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.

• Brand Name: HERO 100
• Common Device Name: DISPENSER, SOLID MEDICATION
• Manufacturer (Section D): HERO HEALTH, INC; 85 broad street; new york NY 10004
• Manufacturer (Section G): HERO HEALTH, INC; 85 broad street; new york NY 10004
• Manufacturer Contact: fred tobia ; 85 broad street; new york, NY 10004 ; 8558559962
• MDR Report Key: 16521414
• Report Number: 3014660737-2023-49231
• Device Sequence Number: 18475987
• 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): 03/07/2023

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: 02/15/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• 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: BUSPIRONE HCL 15 MGCYMBALTA 60 MGCYMBALTA 30 MG; BUSPIRONE HCL 15 MGCYMBALTA 60 MGCYMBALTA 30 MG
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown