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

Model Number 4901730150118

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

Patient Problems Pain (1994); Peeling (1999); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identification, weight and ethnicity were not provided for reporting.This report is for (band aid brand frozen 20s (jp 2016) ap 4901730150118 0037601187apa ).Device is not distributed in the united states but is similar to device marketed in the usa (band aid brand decorated waterproof bandages princess 15ct usa 381371190539 381371190539usa 381371190539usa).Upc = (b)(4).Lot number = (10)ni expiration date = na udi: (b)(4).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 (band aid brand decorated waterproof bandages princess 15ct usa 381371190539 381371190539usa).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 this initial medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

A mother reported an event with band aid brand waterblock decorated.When the reporter¿s (b)(6)-year-old daughter (consumer) got a scratch on her thigh several days after the reporter purchased the product, the reporter applied it to the consumer¿s scratch.About 4 hours after the reporter applied the product, she tried to remove the strip because she gave the consumer a bath.The consumer complained of pain at that time because of too strong adhesion of the product.When the reporter took the time to remove it slowly, the consumer¿s skin of the application site of the tape part peeled off and became inflamed.As of this reporting, the consumer¿s symptom resolved with a drug prescribed by a dermatologist.

• Brand Name: BAND AID BRAND WATERBLOCK DECORATED 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): J&J CHINA SJJP - CHINA (SHANGHAI ); 120 nan ya road; minghang, shanghai 20024 5; CH 200245
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 10489056
• MDR Text Key: 205590399
• Report Number: 1000599868-2020-00010
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 4901730150118
• UDI-Public: (01)4901730150118(10)NI
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730150118
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR