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

Model Number 4901730230308

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

Patient Problems Itching Sensation (1943); Peeling (1999); Blister (4537); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/06/2024

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 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.A4, a5; weight, ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for (band aid brand sheer bandages 50ct ap 4901730230308 4901730230308apa 4901730230308apa).Device is not distributed in the united states, but is similar to device marketed in the usa (bab sheer 1inx3in usa 38137004770 8137004770usa 8137004770usa), lot # 240108.D4: udi #: (b)(4).Upc #: 4901730230308 expiration date: 12/07/2026 lot # 240108 d9, h3, h6: the device was received and the product evaluation is in progress.H4, h6: device evaluation/investigation could not be completed.A review of the device history records has been requested.H6: health effect clinical code: e1708 also refers to consumer alleged "felt an itch".E1703 also refers to consumer alleged "blister appeared on an area where the tape part had been applied".E2402 refers to consumer "intentional misuse/off-label use" of the product and ¿product used for white skin disease and it was completely cured" of the product.Two medwatches (1000599868-2024-00004 & 2214133-2024-00018) are being submitted as two devices were involved with the same event description.See medwatch 1000599868-2024-00004 & 2214133-2024-00018.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An 84-year-old male consumer noticed white skin disease on the tip of his thumb and visited a hospital whereby he was prescribed an antibiotic ointment for his thumb.Consumer stated he applied one strip of unspecified band-aid brand bandage to protect the disease.Subsequently he applied one strip of band aid brand sheer bandage and applied finger cot over the product.Consumer stated he felt an itch and removed the product.A blister appeared on the area where the tape part had been applied and he discontinued using the product.The next day the consumer applied a steroid ointment to the blister at his own discretion.Consumer reported the blister was getting worse and his skin peeled off and was in terrible condition.Consumer stated he thought the symptom might also be affected by steroids.Consumer visited a dermatologist and was prescribed another unspecified medication.The dermatologist requested the consumer to stop using the steroid ointment.Consumer then reported white skin disease was completely cured.Two medwatches (1000599868-2024-00004 & 2214133-2024-00018) are being submitted as two devices were involved with the same event description.See medwatch 1000599868-2024-00004 & 2214133-2024-00018.

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 h2, 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 january 8, 2024.H3, h6: a manufacturing investigation was performed for the subject device, it was confirmed that the visual inspection found no manufacture related issues.If information is obtained that was not available for this follow-up 02 medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: BAND AID BRAND SHEER 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): SHANGHAI JOHNSON & JOHNSON LTD; 120 nan ya road; minghang, shanghai 20024 5; CH 200245
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 19148758
• MDR Text Key: 340682002
• Report Number: 1000599868-2024-00004
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 4901730230308
• UDI-Public: (01)4901730230308(17)261207(10)240108
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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: 4901730230308
• Device Lot Number: 240108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2024
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male