MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DERMACEA; BANDAGE, ELASTIC

Model Number 441501

Device Problem Use of Device Problem (1670)

Patient Problem Tissue Breakdown (2681)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

Eeg did skin check today and saw that under the tape/leads there are multiple sites of skin breakdown from the tape/hat that sits around patients head to keep the leads in place.Eeg was removed and wound care applied.Upon further review from eeg tech, it was thought this pressure injury was related to the gauze roll holding the leads in place.Areas of unstageable pressure injury to forehead.

• Brand Name: DERMACEA
• Type of Device: BANDAGE, ELASTIC
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15248659
• MDR Text Key: 298128720
• Report Number: 15248659
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 441501
• Device Catalogue Number: 441501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2022
• Date Report to Manufacturer: 08/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23360 DA
• Patient Sex: Female
• Patient Weight: 38 KG
• Patient Race: Black Or African American