MAUDE Adverse Event Report: ETHICON DURABOND, DERMABOND

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Wound Dehiscence (1154)

Event Date 03/21/2017

Event Type  No Answer Provided  

Event Description

My child had an injury which the er staff deemed severe enough to address.They glued it shut with durabond, then gave us aftercare instructions to use topical antibiotics and sent us home with petroleum based antibiotic cream.It is known (but was not to me or the medical staff in question) petroleum loosens and/or dissolves durabond the wound then reopened roughly a day later.Do you still have the product in case we need to evaluate it: no.Do you still have the product in case we need to evaluate it: no.

• Brand Name: DURABOND, DERMABOND
• Type of Device: DURABOND, DERMABOND
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6499820
• MDR Text Key: 73221857
• Report Number: MW5069139
• Device Sequence Number: 1
• Product Code: MPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• 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: 5 YR