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

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  

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 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 unspecified ap not applicable 0000rgebabapd 0000rgebabapd).Device is not distributed in the united states, but is similar to device marketed in the usa (band-aid unspecified usa not applicable babgenusunsp babgenusunsp), lot # ni.D4: udi, upc, lot number and expiration date are not available.D9, h3: device is not expected to be returned for manufacturer review/investigation.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.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.

• Brand Name: BAND AID BRAND UNSPECIFIED
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview rd.; skillman NJ 08558 9418
• Manufacturer (Section G): SKILLMAN CONTRACT; 199 grandview road; skillman NJ 08558 9418
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 19148755
• MDR Text Key: 340681892
• Report Number: 2214133-2024-00018
• Device Sequence Number: 1
• Product Code: KGX
• 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
• Report Date: 04/07/2024

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
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male