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

Model Number	ML02-0127
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The caller stated that she did not swallow the rapicide opa/28 high-level disinfectant but ingested it.Steris made multiple attempts to obtain additional information from the caller subject of the reported event however, to date, no additional information has been obtained.Indications for use: rapicide opa/28 high-level disinfectant is a solution for reprocessing of heat sensitive semi-critical medical devices for which sterilization is not suitable.The rapicide opa/28 high-level disinfectant label provides the following language and guidance related to ingestion, "avoid ingestion or contamination of food.Ingestion may cause irritation or chemical burns of the mouth, throat, esophagus and stomach.If swallowed, do not induce vomiting.Drink large quantities of water and call a physician immediately.Probable mucosal damage from oral exposure may contraindicate the use of gastric lavage." a follow-up report will be submitted should additional information become available.
Event or Problem Description
Steris received a phone call from a person who was calling from their home and stated she had "ingested" rapicide opa/28 high-level disinfectant.The caller had stated that she purchased the rapicide opa/28 high-level disinfectant on the internet.The caller was advised by the steris technical service representative to seek medical attention.

• Brand Name: RAPICIDE OPA/28 HIGH-LEVEL DISINFECTANT
• Common Device Name: DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 17315935
• Report Number: 2150060-2023-00036
• Device Sequence Number: 19832447
• Product Code: MED
• UDI-Device Identifier: 00677964054266
• UDI-Public: 00677964054266
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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: Health Professional
• Device Model Number: ML02-0127
• Device Lot Number: 415863
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown