MAUDE Adverse Event Report: HOPKINS UNIFORM COMPANY HOPKINS MEDICAL PRODUCTS® PDI SANI-CLOTH AF3; DISINFECTANT, MEDICAL DEVICES

Model Number 692965

Device Problem Fungus in Device Environment (2316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2019

Event Type  malfunction  

Event Description

Mold growing in sani-wipes container when seal initially removed.It was only the one container so far.The manufacturer rep has also been notified and is meeting with infection control this week.

• Brand Name: HOPKINS MEDICAL PRODUCTS® PDI SANI-CLOTH AF3
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): HOPKINS UNIFORM COMPANY; 6850 southbelt drive; caledonia MI 49316
• MDR Report Key: 8284358
• MDR Text Key: 134315673
• Report Number: 8284358
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 692965
• Device Catalogue Number: 692965
• Device Lot Number: 23:19 280 03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1