MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM; DRESSING,WOUND,OCCLUSIVE

Model Number 187955

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

Patient Problems Peeling (1999); Skin Irritation (2076); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: (b)(4).

Event Description

The nurse reported partial and full thickness skin loss when an unknown number of dressings from an unknown number of boxes were removed from skin on patient's head.She said it was like the skin had been removed the way it was for a skin graft.She did not feel 100 percent that the duoderm extra thin dressing was causing this because the patient was compromised and in prone position for extended periods of time.All she knew was when the dressing was removed, the patient had open wounds immediately after removing the dressing and these areas were not present upon application.Reportedly, they had been using these dressings on covid patient's face for pressure injury prevention since the patient was in prone position for 16-18 hours per day.The patient was on ventilator.The nurses were removing the dressings within 24 hours because of the secretions on the patient's face, which was not related to the dressing.She wanted to confirm that the dressing could be left in place for up to 7 days.When the wound care team applied the dressing, they applied a protective barrier wipe prior to application but she was unsure of how the dressing was applied by the non-wound care team.No prescription medication was provided.The patient was already in the hospital receiving care.They did not continue to use the product on the patient.The nurse was educating on the use of protective barrier wipes prior to application.No photo is available at this time.

• Brand Name: L3W0750 - DUODERM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 11153305
• MDR Text Key: 226553198
• Report Number: 9618003-2021-00033
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 187955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1