MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND BANDAGES BABY SHARK; TAPE AND BANDAGE, ADHESIVE

Model Number 381371194544

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

Patient Problem Contact Dermatitis (4546)

Event Date 03/03/2022

Event Type  Injury  

Event Description

A consumer reported an event with band aid brand bandage baby shark.Consumer reported her daughter had a cut on her arm and therefore used the baby shark band-aid bandage on (b)(6) 2022.After taking the product off, the daughter had redness on her arm.As days passed, the redness became worse and she developed blisters and pain.The mother took the daughter to see her allergist and her allergist stated she was having an allergic reaction to the band-aids (contact allergic dermatitis).On (b)(6) 2022 the daughter was admitted to the hospital.Steroids were administered for treatment.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight and ethnicity and race were not provided for reporting.This report is for one (1) band aid brand bandages baby shark assorted 20ct usa (b)(4) lot number ni.Udi #: (b)(4), upc #: 381371194544, lot #: ni, exp date: na.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BAND AID BRAND BANDAGES BABY SHARK
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 13944595
• MDR Text Key: 293157809
• Report Number: 8041154-2022-00003
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371194544
• UDI-Public: (01)381371194544
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381371194544
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 MO
• Patient Sex: Female