MAUDE Adverse Event Report: MEDIVATORS, INC. RAPICIDE OPA/28 HIGH LEVEL DISINFECTANT

Model Number ML02-0127

Device Problem Insufficient Information (3190)

Patient Problem Headache (1880)

Event Date 01/13/2023

Event Type  malfunction  

Event Description

The user facility reported via chemtrec report that an individual "developed a headache" and "irritation to her uvula" from ingestion exposure to rapicide opa high level disinfectant.The individual sought medical treatment, but it is unknown if treatment was administered.

Manufacturer Narrative

The report did not identify the contact information or location of the user of the product in question therefore, additional information could not be obtained.To-date we have not been informed of this event directly from the user.Should additional information become available a follow-up report will be submitted.

• Brand Name: RAPICIDE OPA/28 HIGH LEVEL DISINFECTANT
• Type of Device: DISINFECTANT
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 16426588
• MDR Text Key: 310188291
• Report Number: 2150060-2023-00014
• Device Sequence Number: 1
• Product Code: MED
• UDI-Device Identifier: 00677964054266
• UDI-Public: 00677964054266
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ML02-0127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2023
• 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