MAUDE Adverse Event Report: MAVIDON MEDICAL PRODUCTS MAVIDON COLLODION REMOVER 128 OZ GALLON; SOLVENT, ADHESIVE TAPE

Lot Number L2019E

Device Problem Nonstandard Device (1420)

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

Event Date 12/23/2019

Event Type  No Answer Provided  

Event Description

Product recall, collodion remover.Product recall (b)(6) 2019.

• Brand Name: MAVIDON COLLODION REMOVER 128 OZ GALLON
• Type of Device: SOLVENT, ADHESIVE TAPE
• Manufacturer (Section D): MAVIDON MEDICAL PRODUCTS
• MDR Report Key: 9559339
• MDR Text Key: 174135467
• Report Number: MW5092078
• Device Sequence Number: 1
• Product Code: KOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2020

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?: No
• Device Operator: No Information
• Device Lot Number: L2019E
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1