MAUDE Adverse Event Report: UNKNOWN DOSETTE BOXES; DISPENSER, LIQUID MEDICATION

Device Problems Unsealed Device Packaging (1444); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Other  

Event Description

I am a care manager, on the x xxx, i received my monthly dosette boxes order from my local pharmacy xxxxxx in xxxxxxxx.My staff checked the dosette boxes only to find that 8 boxes had not been sealed, hence tables in the wrong compartment.I raised this issue with the pharmacy, only to be told they were short staff, and that they were sorry.I explained they had a responsibility to ensure safe dispensing of medication.Only to be told again they were short staffed.I have taken photos of the dosette boxes.(b)(6); email: (b)(6).Submission id: (b)(4).Reference reports: mw5119001, mw5119002, mw5119003, mw5119004, mw5119005, mw5119006, mw5119007.

• Brand Name: DOSETTE BOXES
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17238294
• MDR Text Key: 318357679
• Report Number: MW5119000
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1