MAUDE Adverse Event Report: CONVATEC INC. EASYDERM XTHIN 10X10CM OTC; DRESSING,WOUND,OCCLUSIVE

Model Number 412002

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Damage (2104)

Event Date 07/21/2016

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.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.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on september 21, 2016 (b)(4).

Event Description

It was reported the caregiver applied the duoderm extrathin on the (b)(6) baby's chin on (b)(6) 2016.On (b)(6) 2016 the caregiver removed the duoderm extrathin from the chin although it was hard to remove due to the adhesive strength.The size of the wound on the chin eventually got bigger due to the epidermis around the original wound peeling with removal of the duoderm extrathin; however the area looked red before removing the duoderm extrathin.The baby went back to the hospital on (b)(6) 2016 and the doctor prescribed an ointment for the wound to be used after disinfection of the wound.The caregiver discontinued use of the duoderm extrathin.Per additional information received (b)(6) 2016, the wound on the chin has slightly recovered but the scar has remained.

• Brand Name: EASYDERM XTHIN 10X10CM OTC
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5967901
• MDR Text Key: 55314718
• Report Number: 1049092-2016-00406
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 412002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 MO