MAUDE Adverse Event Report: THE RUHOF CORPORATION CLEAN START BEDSIDE CLEANING KIT; CLEANER, ULTRASONIC, MEDICAL INSTRUMENT

Lot Number 8327 "+8386"

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2023

Event Description

Ruhof cleanstart bedside cleaning kit was contaminated.

• Brand Name: CLEAN START BEDSIDE CLEANING KIT
• Type of Device: CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
• Manufacturer (Section D): THE RUHOF CORPORATION
• MDR Report Key: 16305112
• MDR Text Key: 308958061
• Report Number: MW5114692
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 8327 "+8386"
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1