MAUDE Adverse Event Report: MEDLINES INDUSTRIES SKIN AFFIX; TAPE AND BANDAGE ADHESIVE

Device Problems Use of Device Problem (1670); Material Protrusion/Extrusion (2979)

Patient Problems Injury (2348); Chemical Exposure (2570)

Event Type  Injury  

Event Description

Two physician operators at our institution have been injured by using the medline skin affix topical skin adhesive.When squeezing the vial glass within the vial has penetrated the plastic shell, penetrated physician gloves and skin, resulting in exposures.Dates of use: (b)(6) 2017.Diagnosis or reason for use: topical skin adhesive when closing wounds.

• Brand Name: SKIN AFFIX
• Type of Device: TAPE AND BANDAGE ADHESIVE
• Manufacturer (Section D): MEDLINES INDUSTRIES
• MDR Report Key: 6732288
• MDR Text Key: 80790216
• Report Number: MW5071128
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other