MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID DECORATED BANDAGES; ADHESIVE BANDAGES

Model Number 381371165896

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

Patient Problems Burn(s) (1757); Pain (1994); Peeling (1999)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Weight and ethnicity were not provided for reporting.This report is for (band-aid deco paw patrol assorted 20s (b)(4)).Device is not distributed in the united states, but is similar to device marketed in the usa (bab paw patrol bandages assorted 20ct usa (b)(4)).Udi #: (b)(4).Upc #: (b)(4), lot #: 2300b, exp date: na.Device is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states but is similar to device marketed in the usa (bab paw patrol bandages assorted 20ct usa (b)(4)).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 august 17, 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 patient¿s mother and involved a (b)(6) year-old girl using band-aid decorated paw patrol adhesive bandages (assorted 20s) (lot 23008).No details about patient¿s medical history, concomitant medications, height or weight were reported.The patient used the bandage on (b)(6) 2021 to cover a wound.While removing it on the same day, the bandage burnt and pulled the skin off.The mother applied polysporin on the wound to help with the pain.On an unspecified day, a doctor was consulted who said that the child¿s skin was burnt.The doctor prescribed polysporin and steroid cream as treatment.As of (b)(6) 2021, the child had not yet recovered.

• Brand Name: BAND AID DECORATED BANDAGES
• Type of Device: ADHESIVE BANDAGES
• 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: 11314588
• MDR Text Key: 238600107
• Report Number: 8041154-2021-00005
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371165896
• UDI-Public: (01)381371165896(10)2300B
• 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: 01/18/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381371165896
• Device Lot Number: 2300B
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR