MAUDE Adverse Event Report: MAVIDON MEDICAL PRODUCTS COLLODION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Scarring (2061); Skin Inflammation (2443)

Event Date 09/13/2019

Event Type  Injury  

Event Description

The use of collodion during a veeg left patient with severe contact dermatitis and blistering resulting in facial scars.

• Brand Name: COLLODION
• Type of Device: COLLODION
• Manufacturer (Section D): MAVIDON MEDICAL PRODUCTS
• MDR Report Key: 9495876
• MDR Text Key: 172404237
• Report Number: MW5091757
• Device Sequence Number: 1000
• 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: Other
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 2 YR
• Patient Weight: 13