MAUDE Adverse Event Report: MAVIDON MEDICAL PRODUCTS MAVIDON LEMON PREP; DEGREASER, SKIN, SURGICAL

Lot Number 30675

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Rash (2033); Burning Sensation (2146)

Event Date 09/16/2019

Event Type  Injury  

Event Description

Pt felt that her skin was burning, left a rash and a burn on the areas it was applied on.

• Brand Name: MAVIDON LEMON PREP
• Type of Device: DEGREASER, SKIN, SURGICAL
• Manufacturer (Section D): MAVIDON MEDICAL PRODUCTS
• MDR Report Key: 9271680
• MDR Text Key: 165226265
• Report Number: MW5090843
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/26/2020
• Device Lot Number: 30675
• 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
• Patient Age: 60 YR
• Patient Weight: 130