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

Model Number 4901730180450

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

Patient Problem Purulent Discharge (1812)

Event Type  Injury  

Event Description

An (b)(6) consumer stated that they used band-aid kizu power pad plus big size 6ct ap (kkp), to treat a wound and became purulent.The consumer stated they used two kinds of kpp.The consumer stated they gotten the wound because they scratched their arm on a telephone pole about one week prior to this reporting.The consumer initially applied an adhesive tape manufactured by another company, but the skin on the tape part became irritated, so they changed it to kpp plus large.The consumer changed the product every day because a lot of lymph fluid was discharged.Consumer ran out of kpp plus large and purchased kpp large at a convenience store near their house.The consumer applied kpp large until the morning on the day of this reporting.The consumer stated they saw a physician in the morning on the day of this reporting and was told not to apply kpp because the wound became purulent.The consumer was prescribed an antibiotic.Consumer did not identify the antibiotic they were prescribed nor dosage and frequency.Consumer followed-up to see the physician again on (b)(6)2021.The consumer stated there was no problem because the wound already subsided.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2021-00047.The same patient is represented in each medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, gender, weight and ethnicity were not provided for reporting.This report is for (band-aid kizu power pad plus big size 6ct ap 4901730180450 79606722apa 79606722apa).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).(b)(4).Upc #: 4901730180450.Expiration date: na.Lot #: ni.Device is not expected to be returned for manufacturer review/investigation g3: 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).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.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2021-00047.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, an additional 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 road; 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: 12809966
• MDR Text Key: 285248011
• Report Number: 2214133-2021-00048
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730180450
• UDI-Public: (01)4901730180450(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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730180450
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/20/2021
• 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: 89 YR