MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND BREATHABLE BANDAGES AP 1361CAP; TAPE AND BANDAGE, ADHESIVE

Model Number 6916999215513

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

Patient Problems Erythema (1840); Itching Sensation (1943); Discomfort (2330)

Event Date 03/17/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, weight, and ethnicity and race were not provided for reporting.This report is for band-aid breathable 8ct ap 6916999215513 0037206180apa 0037206180apa.Device is not distributed in the united states.Band-aid breathable 8ct ap 6916999215513 0037206180apa 0037206180apa is similar to device marketed in the usa (bab sheer 1inx3in usa 38137004770 8137004770usa 8137004770usa).Udi #: (b)(4).Upc #: 6916999215513.Lot #: 200413 1813.Exp: 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 sheer 1inx3in usa 38137004770 8137004770usa 8137004770usa).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.A review of the device history records has been requested.This is 1 of 2 med-watches being submitted, as it was unknown which band-aid product was involved in this event.See medwatch 1000599868-2021-00005.The same patient is represented in each medwatch.If information is obtained that was not available for this initial medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported an event for pediatric consumer (b)(6) using band-aid breathable ap for a skin scratch.The consumer purchased a bandage from the hospital on (b)(6) 2021 and took it home and applied it to the skin scratch of the consumer¿s right hand.Around noon time of (b)(6) 2021, the pediatric consumer had developed itchy skin and stopped using the bandage.Consumer visited a hospital for treatment.The consumer showed mild skin redness at the scratch site.The bandage was discontinued, and the patient and was given fluocinonide cream (to prevent infection and to accelerate healing) for application after examination.The consumer returned home and was told to keep it under observation.The consumer was followed up for discomfort.This is 1 of 2 med-watches being submitted, as it was unknown which band-aid product was involved in this event.See medwatch 1000599868-2021-00005.The same patient is represented in each medwatch.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes and admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H4, h6: 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 april 13, 2020.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: BAND AID BRAND BREATHABLE BANDAGES AP 1361CAP
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 11729521
• MDR Text Key: 252324091
• Report Number: 1000599868-2021-00004
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6916999215513
• Device Lot Number: 200413 1813
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 05/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 06 YR