MAUDE Adverse Event Report: BAND-AID® BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC; ADHEISVE BANDAGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Pain (1994)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age, weight, ethnicity and race information was not provided for reporting.This report is for one (1) band-aid® brand adhesive bandages flexible fabric, lot# was not provided and udi# is not available.Device is not expected to be returned for manufacturer review/investigation device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.There is a caution warning on the packaging and on the individual wrapper label stating: the packaging of this product contains natural rubber latex which may cause allergic reactions.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A consumer called to report her throat closing and her hands burning upon using a flexible fabric band aid.The consumer is allergic to latex.A consumer alleged that latex is not stated on the package.Consumer disconnected call and provided no call back information.

• Brand Name: BAND-AID® BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC
• Type of Device: ADHEISVE BANDAGE
• Manufacturer Contact: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 7550754
• MDR Text Key: 109456266
• Report Number: 2214133-2018-00008
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention