MAUDE Adverse Event Report: DERMABOND

Lot Number LBE683

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burning Sensation (2146)

Event Date 05/31/2017

Event Type  Injury  

Event Description

Dermabond was applied to a wound and the patient complained of burning sensation.Pa checked it on her own hand and it was burning and left a mark on her skin.Pa picked one with a different expiration date and it caused a burning sensation as well.The supply was pulled from the ed and the supply chain vp notified and will reach out to the company.Lot lbe683 exp 01/31/2019.

• Brand Name: DERMABOND
• Type of Device: DERMABOND
• MDR Report Key: 6614031
• MDR Text Key: 76901724
• Report Number: MW5070165
• Device Sequence Number: 1
• Product Code: OMD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2019
• Device Lot Number: LBE683
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR