MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB DECORATED WATERPROOF BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 381371190553

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

Patient Problem Anaphylactic Shock (1703)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight, and ethnicity and race were not provided for reporting.Udi #:(b)(4).Upc #: 381371190553.Lot #: 0650b.Expiration date - na.Device is not expected to be returned for manufacturer review/investigation.This report is for (band aid brand decorated waterproof bandages mickey 15ct can 381371190553 381371190553caa 381371190553caa).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand decorated waterproof bandages mickey 15ct usa 381371190553 381371190553usa 381371190553usa).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand decorated waterproof bandages mickey 15ct usa 381371190553 381371190553usa 381371190553usa).Device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on march 5, 2020.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This incident was reported by the patients mother and involved a (b)(6) girl (dob (b)(6)) using band-aid brand bandages waterproof mickey (15 count) (lot 0650b).The device was only used once.Patients medical history included sesame oil allergy.Concomitant medications, height or weight were not reported.On (b)(6) 2021, the child used 1 bandage to cover a bleeding cut.On the same day, she experienced a severe allergic reaction requiring 911 emergency assistance.Epipen was administered and childs heart was monitored.The child was admitted to the hospital on (b)(6) 2021 and released on the same day.The child recovered on (b)(6) 2021.

• Brand Name: BAB DECORATED WATERPROOF BANDAGES
• 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: 12373909
• MDR Text Key: 268352412
• Report Number: 8041154-2021-00024
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371190553
• UDI-Public: (01)381371190553(10)0650B
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381371190553
• Device Lot Number: 0650B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 6 YR