MAUDE Adverse Event Report: SURGICAL GLUE; GLUE, SURGICAL, ARTERIES

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Swelling/ Edema (4577)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Patient called to report an adverse reaction she experienced to surgical glue that was used on her a few years ago.Patient stated that she experienced an allergic reaction with red, swollen, itchy skin.Patient stated it took a long time for the reaction to clear up.

• Brand Name: SURGICAL GLUE
• Type of Device: GLUE, SURGICAL, ARTERIES
• MDR Report Key: 12245696
• MDR Text Key: 264346329
• Report Number: MW5102849
• Device Sequence Number: 1
• Product Code: MUQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/28/2021

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?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR