MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER; TAPE AND BANDAGE

Model Number 381370046691

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Tissue Injury (4559)

Event Date 08/20/2023

Event Type  Injury  

Event Description

Fda shared a consumer reported event, via mw5144875, regarding an unknown consumer who stated the following: ¿i purchased band-aid true-stay sheer 80 assorted sizes by johnson+johnson.The product did not include the list of harmful chemicals and allergens and was marketed as safe for use.Patent #(b)(4).I had a severe reaction to the secret use of nickel.I am deathly allergic and almost lost my finger after 10-mins of exposure.Require every single product advertised as a health product to include hazardous chemicals, common allergens, and poisonous substances.I should not almost loose my finger from "allergy safe" branded band-aids.Shame on you for allowing this intentional disregard for the safety of humanity.Outcomes attributed to adverse event: required intervention, other serious or important medical event, life threatenin.¿.

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, a3, a4, a5: patient identifier, patient age, gender, weight, and ethnicity and race were not provided for reporting.B2: this event will be categorized as a serious injury- other serious or important medical event.Although the consumer checked off ¿outcomes attributed to adverse event: required intervention, other serious or important medical event, life threatenin¿ on mw5144875, scant information is available to provide a more meaningful assessment of the case, such as the time to onset of the events and product use is not clear to establish a temporal relationship between the event and the product; nature of the injury; furthermore there are no details on the medical history, progression of the condition, results of medical consultations or diagnostics done, treatment and the outcome.There is insufficient information to conclude whether a permanent injury or impairment occurred.There is no consumer contact information and no additional information can be obtained.Should additional information become available, this file and assessment will be reviewed again accordingly.Moreover, the raw material documentation for the adhesive and backing of band aid brand tru stay sheer bandages were reviewed and state that nickel is not present in the product.D1, d2, d3, d4: this report is for one (band aid brand tru stay sheer bandages 80ct usa 381370046691 381370046691usa 381370046691 usa lot/ctrl # ni.D4: udi #: (b)(4).Upc #: 381370046691.Lot #: ni.Expiration date: na.D10: device is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.The raw material documentation for the adhesive and backing of band aid brand tru stay sheer bandages were reviewed and state that nickel is not present in the product.H6: health effect clinical code: e0402 also refers to consumer alleged about ¿allergic reaction (had a severe reaction described as almost lost finger.) 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 TRU STAY SHEER BANDAGES / SHEER
• Type of Device: TAPE AND BANDAGE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 17840428
• MDR Text Key: 324558935
• Report Number: 8041154-2023-00024
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381370046691
• UDI-Public: (01)381370046691(10)NI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2023

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: 381370046691
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other