MAUDE Adverse Event Report: MOLNLYCKE HEALTHCARE, US LLC NORMLGEL AG; DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC

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

Patient Problem Pain (1994)

Event Date 03/12/2020

Event Type  Injury  

Event Description

Extreme pain when product applied to my skin lesions.

• Brand Name: NORMLGEL AG
• Type of Device: DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE, US LLC
• MDR Report Key: 9847998
• MDR Text Key: 184250404
• Report Number: MW5093813
• Device Sequence Number: 1
• Product Code: MGQ
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 111