MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX; TAPE AND BANDAGE, ADHESIVE

Model Number 381371183494

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

Patient Problems Skin Tears (2516); Caustic/Chemical Burns (2549); Contact Dermatitis (4546)

Event Date 09/06/2023

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 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 adhesive bandage skin flex with motion max extra large 7ct usa 381371183494, lot number ni.D4: udi #(b)(4), upc #381371183494, expiration date: na, lot #ni.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 code: e170401 also refers to consumer alleged about "melted brown & blistered where the adhesive was touching/ the chemical burn".E1721 also refers to consumer alleged about "largest chunk of bubbled/blistered skin came off with bandaid, indented raw portion/ still painful".If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A father reported an adverse event for his three-year-old son who used a band aid brand adhesive bandage skin flex with motion max extra large.On (b)(6) 2023, the bandage was used for scrape on arm and the son had a reaction on (b)(6) 2023.Consumer washed son¿s wound with soap and water and put neosporin and product on the skin.Consumer reported son¿s skin appeared melted brown and blistered where the adhesive was touching skin.Consumer reported that the largest chunk of bubbled/blistered skin came off with the band-aid and there is an indented raw portion.The consumer reported the bubbled skin came off with the gauze and that he did not mean to put band-aid there.Consumer consulted pediatrician and son was treated with prescribed topical medication, such as mupirocin, an unknown ointment and silver sulfadiazine.Consumer also reported that prescribed sulfur dioxide cream is helping the blister heal.Consumer stated that the doctor recommended an ointment twice a day in a gauze and then wrapping it with self-adhesive, so that nothing would stick to son's skin.The son is no longer experiencing any symptoms and the event resolved on (b)(6) 2023.

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.Additional information: a4 - weight 33lb.B5 - additional information was received as a part of the patient's medical record at the time of the doctor's visit on (b)(6) 2023: 2 nights ago was running around at home and scraped l forearm on corner of wall.Mom washed with soap and water and applied antibiotic ointment and bandaid.Yesterday morning washed with hibiclens and rebandaged.Last night, mom removed bandaid as patient was complained pain and had some seepage and noted significant erythema and blisters where bandaid was.Typically uses only hydrocolloid bandaids, but only had regular ones this time.Doctor's diagnoses at the time of the visit on (b)(6) 2023: contact dermatitis caused by adhesive bandage.Icd-10 l25.3 unspecified contact dermatitis due to other chemical products.E172003 - refers to the patient was diagnosed with contact dermatitis caused by adhesive bandage.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Additional information was received as a part of the patient's medical record at the time of the doctor's visit on (b)(6) 2023: 2 nights ago was running around at home and scraped l forearm on corner of wall.Mom washed with soap and water and applied antibiotic ointment and band-aid.Yesterday morning washed with hibiclens and re-bandaged.Last night, mom removed band-aid as patient was complained pain and had some seepage and noted significant erythema and blisters where band-aid was.Typically uses only hydrocolloid band-aids, but only had regular ones this time.Doctor's diagnoses at the time of the visit on (b)(6) 2023: contact dermatitis caused by adhesive bandage.Icd-10 l25.3 unspecified contact dermatitis due to other chemical products.

• Brand Name: BAND AID BRAND ADHESIVE BANDAGE SKIN FLEX WITH MOTION MAX
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; 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: 17859609
• MDR Text Key: 324775782
• Report Number: 8041154-2023-00025
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 381371183494
• UDI-Public: (01)381371183494(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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

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: 381371183494
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: NEOSPORIN
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 15 KG