MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES; DRESSING, WOUND, OCCLUSIVE

Model Number 4901730021913

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

Patient Problems Bacterial Infection (1735); Blister (4537); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/16/2023

Event Type  Injury  

Event Description

A female consumer reported she injured her knee.She saw an orthopaedic surgeon, and band-aid hydro seal bandages was recommended.Therefore, she applied band-aid hydro seal bandages large on the knee on the same day, and then redness and itching developed around the wound.Since the body fluid leaked because the wound was large, she replaced the strip with a hydrocolloid pad (other manufacture apos;s product).After that, the wound swelled, and urticaria developed around the wound.The wound became small, and so she replaced the strip with band-aid hydro seal bandages large again.After that, itching and a blister developed.She saw a dermatologist.She was told that the cause was bacterial infection and to stop using band-aid hydro seal bandages.She stopped using it, and the wound was treated with gauze and a bandage.Farom tab.200mg (faropenem sodium hydrate), tsumura jumihaidokuto extract granules (platycodon root/bupleurum root/cnidium rhizome/poria sclerotium/quercus bark/aralia rhizome/saposhnikovia root/glycyrrhiza/schizonepeta spike/ginger), fucidin leo ointment 2% (sodium fusidate), and sofuratulle gauze dressing (fradiomycin sulfate) were prescribed.The symptoms healed.Consumer saw another dermatologist and was told to receive a patch test because the possible cause was allergy.On the same date, she applied band-aid hydro seal bandages blister on the inside of the left arm.The consumer applied it on the inside of the left arm for a patch test.About 6 hours after applying the strip, a blister developed on the area where the strip was applied.This is one of two medwatches being submitted as two devices were involved in this event.(pqms#80000270726) is for band-aid hydro seal bandage large 6 strips and (pqms#80000270845) is for band-aid hydro seal bandage blister.See medwatch 2214133-2023-00023.The same patient is represented in each medwatch.

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 (band aid brand kizu power pad (kpp) large 6ct ap 4901730021913 4901730021913apb 4901730021913apb).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa 8137117533usa).D4: udi#: (b)(4); upc#: 4901730021913; lot#: ni; exp date: ni.D10: device is not expected to be returned for manufacturer review/investigation.D10: concomitant medial product #2: tsumura jumihaidokuto extract granules (platycodon root/bupleurum root/cnidium rhizome/poria sclerotium/quercus bark/aralia rhizome/saposhnikovia root/glycyrrhiza/schizonepeta spike/ginger).Concomitant medial product #5: a hydrocolloid pad (other manufacture's product).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: e1901 also refers to consumer alleged about "skin structure and soft tissue infection and health care professional (hcp) diagnosed as bacterial infection subsumed redness, itching, fluid discharge".E2402 refers to consumer "intentional misuse/off-label use" of the product.This is one of two medwatches being submitted as two devices were involved in this event.(pqms#80000270726) is for band-aid hydro seal bandages large 6 strips and (pqms#80000270845) is for band-aid hydro seal bandages blister.See medwatch 2214133-2023-00023.The same patient is represented in each medwatch.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 KPP (KIZU POWER PAD) BANDAGES
• 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: 17203026
• MDR Text Key: 317993772
• Report Number: 2214133-2023-00022
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730021913
• UDI-Public: (01)4901730021913(10)NI
• 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: 06/07/2023

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: 4901730021913
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: A BANDAGE.; BAND-AID HYDRO SEAL BANDAGES BLISTER.; FAROM TAB. 200MG (FAROPENEM SODIUM HYDRATE).; FUCIDIN LEO OINTMENT 2% (SODIUM FUSIDATE).; GAUZE.; HYDROCOLLOID PAD.; SOFURATULLE GAUZE DRESSING (FRADIOMYCIN SULFATE).; TSUMURA JUMIHAIDOKUTO EXTRACT GRANULES.
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female