MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CURAD; TAPE AND BANDAGE, ADHESIVE

Model Number NON25660

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

Situation: moldy band-aid found in med room.Background: i took a few band-aids out of last week.Assessment: i opened one today and found it to be moldy inside.Black mold growing inside the band-aid packaging.You could not see it from the outside of the band-aid.Result: i took a picture of the moldy band-aid and showed it to management.I removed the open band aid box from the room.Manufacturer response for bandaid, band aid 1"x3" (per site reporter).Notified, handed off, and medline opened a complaint for investigation.

• Brand Name: CURAD
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 14487172
• MDR Text Key: 292492567
• Report Number: 14487172
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NON25660
• Device Lot Number: 90921020001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1