MAUDE Adverse Event Report: MAVIDON MEDICAL PRODUCTS COLLODION REMOVER; SOLVENT, ADHESIVE TAPE

Lot Number 30218

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

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

Event Type  No Answer Provided  

Event Description

Mavidon issued a voluntary recall of all products manufactured at their facility including skin preparation cups and remover electrode collodions due to contamination with burkholderia cepacia.

• Brand Name: COLLODION REMOVER
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): MAVIDON MEDICAL PRODUCTS
• MDR Report Key: 9592693
• MDR Text Key: 175370719
• Report Number: MW5092253
• Device Sequence Number: 1
• Product Code: KOY
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/10/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/27/2021
• Device Lot Number: 30218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1