MAUDE Adverse Event Report: MEDIVATORS, INC. RAPICIDE PA HIGH LEVEL DISINFECTANT

Model Number ML02-0117

Device Problem Use of Device Problem (1670)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

The lot of the reported product was not provided and the bottle subject of the event was not returned for evaluation.The duration of symptoms was not reported.Protective gloves were not worn while handling the rapicide pa high level disinfectant bottles and this likely contributed to the reported event.The following language related to safe handling of the rapicide pa high level disinfectant can be found on the sds, "causes skin irritation.Symptoms may include redness, edema, drying, defatting and cracking of the skin.Wash hands thoroughly after handling.Wear protective gloves/eye protection/face protection.If on skin: wash with plenty of water.Take off contaminated clothing and wash it before reuse.If skin irritation occurs: get medical advice/attention." the sds was provided to the user facility which indicates the requirement for ppe during handling of rapicide pa high level disinfectant.No additional reports of adverse event or harm were received.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.

Event Description

The user facility reported that an employee was handling rapicide pa high level disinfectant without wearing gloves.They reported white marks on their right finger following handling of the disinfectant.Medivators was notified of the reported event through chemtrec.The user facility did not disclose if medical treatment was sought or administered.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT
• Type of Device: HIGH LEVEL 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 ; 9800 59th avenue n; minneapolis, MN 55442
• MDR Report Key: 12919192
• MDR Text Key: 289259490
• Report Number: 2150060-2021-00027
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964090172
• UDI-Public: 00677964090172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1