MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND HYDROSEAL BANDAGES LARGE; DRESSING, WOUND, OCCLUSIVE

Model Number 381371174010

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/28/2023

Event Type  Injury  

Event Description

Male consumer reported large band aid brand hydroseal bandage was effective at healing an ulcer he had but caused a hypersensitivity vasculitis reaction in his skin.Consumer was still experiencing the adverse reactions while reporting this event and reported his reactions have improved.Consumer contacted healthcare provider and was recommended to follow up with dermatologist.Emollient & cotton gauze/other silicone bandage products (with silicone adhesive) was used as treatment.

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: patient weight, and ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for one (1) band aid brand hydroseal bandages large 6ct (b)(4), lot number ni.D4: udi #: (b)(4).Upc # 381371174010.Lot number# 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.H6: health effect clinical codes: e0402 also refers to consumer alleged about "hypersensitivity vasculitis reaction in skin".E2402 refers to consumer alleged about "product was effective at healing an ulcer ".E2402 refers to consumer "intentional misuse/off-label use" of the product.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 HYDROSEAL BANDAGES LARGE
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST; coloplast hungary kft.; h-4300 nyirbator; coloplast u.2 ; HU
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 17032735
• MDR Text Key: 316286349
• Report Number: 2214133-2023-00016
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 381371174010
• UDI-Public: (01)381371174010(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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2023

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: 381371174010
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/31/2023
• 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: 30 YR
• Patient Sex: Male