MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND FLEXIBLE FABRIC BANDAGES TOUGH STRIPS; TAPE AND BANDAGE, ADHESIVE

Model Number 9300607179354

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

Patient Problems Skin Erosion (2075); Skin Infection (4544)

Event Date 04/16/2023

Event Type  Injury  

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 an 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.A1, a2, a4, a5: patient identifier, age, weight, ethnicity and race were not available for reporting.D1, d2, d3, d4: this report is for one band aid brand tough strips 40ct ap 9300607179354 9300607179354apa 9300607179354apa, lot number 220715.Device is not distributed in the united states but is similar to device marketed in the usa (bab tough strips 20s usa 381370044086 8137004408usa 8137004408usa).D4: udi: (b)(4).Upc #: 9300607179354.Expiration date: june-15-2025.Lot #: 220715.D10: device is not expected to be returned for manufacturer review/investigation.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 july 15, 2022.H6: health effect clinical codes: e1718 also refers to patient alleged about "horrible raw patch that almost looks like a burn".This is the medwatch one of two to capture the event for daughter who used the band-aid for only 1 day and had a reaction on (b)(6) 2023.See the medwatch 1000599868-2023-00006 which captures the event for the reporter's other daughter who used the band-aid for 2 days and had a reaction on (b)(6) 2023.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The mother reported same adverse event experienced that occurred with both daughters using band aid brand tough strips.Both of her daughters used the band-aid product on (b)(6) 2023.The mother mentioned that her daughters have used band-aid tough strips previously without any issues.As per reporter, on (b)(6) 2023 her first daughter, who used the band-aid to cover the wound for 2 days, experienced reaction described as a raw red patch almost looks like a burn.The symptoms have improved after the daughter stopped using the product.As per reporter, the doctor recommended flucloxacillin, crystaderm, and soban cream for the treatment.The daughter took an oral antibiotic and applied topical creams on the affected area.It was reported that, daughter's infection has healed.This is the medwatch one of two to capture the event for daughter who used the band-aid for only 1 day and had a reaction on (b)(6) 2023.See the medwatch 1000599868-2023-00006 which captures the event for the reporter's other daughter who used the band-aid for 2 days and had a reaction on (b)(6) 2023.

• Brand Name: BAND AID BRAND FLEXIBLE FABRIC BANDAGES TOUGH STRIPS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman 08558 9418
• Manufacturer (Section G): SHANGHAI JOHNSON & JOHNSON LTD; 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: 16911779
• MDR Text Key: 315007102
• Report Number: 1000599868-2023-00005
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 9300607179354
• UDI-Public: (01)9300607179354(17)250615(10)220715
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2023

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: 9300607179354
• Device Lot Number: 220715
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female