MAUDE Adverse Event Report: APOTHECARY PRODUCTS LLC EZY-DOSE; PILL CUTTER

Model Number	67661
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Apothecary products llc., received a report from the customer alleges she had a laceration to her thumb while cutting a pill with our product.She was treated at the emergency room and her cut was treated.The patient bought our product with our customer publix.Our product warning, states that the blad is sharp stainless steel blade, direct contact with the blade needs to be avoided as it is very sharp.

• Brand Name: EZY-DOSE
• Common Device Name: PILL CUTTER
• Manufacturer (Section D): APOTHECARY PRODUCTS LLC; 11750 12th avenue south; burnsville MN 55337
• MDR Report Key: 11580345
• Report Number: 0002183416-2021-00001
• Device Sequence Number: 17363830
• Product Code: OHY
• UDI-Device Identifier: 00025715676616
• UDI-Public: 00025715676616
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2021

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: 67661
• Device Catalogue Number: 67661NI
• Device Lot Number: 150O
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 03/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1