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

Model Number ML02-0127

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 319107132
• Report Number: 2150060-2023-00036
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ML02-0127
• Device Lot Number: 415863
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1