FDA Adverse Event Injury Summary report: N

LIQUIBAND OCTYL MINI

MDR report key: 14580159 · Received June 2, 2022

Report

Report Number
9617175-2022-00027
Event Type
Injury
Date Received
June 2, 2022
Report Date
June 2, 2022
Manufacturer
ADVANCED MEDICAL SOLUTIONS LTD
Product Code
MPN
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 0

UNKNOWN IF DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THERE IS A SMALL PERCENTAGE OF THE POPULATION WITH A NATURAL SENSITIVITY TO CYANOACRYLATE ADHESIVE. THIS IS STATED IN THE INSTRUCTIONS FOR USE (IFU).

Description of Event or Problem · 0

PATIENTS ARE ITCHING AND BREAKING OUT. WE HAVE ORDERED A LOT OF MEDROL DOSE PACKS FOR EXTREME REACTIONS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1978581 LIQUIBAND OCTYL MINI TOPICAL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS LTD 72014023

Patients

Seq Age Sex Outcome Treatment
1 Unknown Other