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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES DRESSING, WOUND, OCCLUSIVE Back to Search Results
Model Number 4901730016322
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Local Reaction (2035); Skin Discoloration (2074); Impaired Healing (2378)
Event Type  Injury  
Event Description
A consumer reported an event with band aid brand kpp (kizu power pad) bandage on (b)(6) 2022. Consumer stated that in (b)(6) 2021, the consumer applied kpp on the right forefinger because of care for chapped skin. The consumer kept the product on for three or four days. The consumer discontinued the use of the product and visited a dermatologist because redness was noted on the area where the product had been applied. The consumer only used one strip of the product once. The consumer used a unknown medicine prescribed by the dermatologist, and the redness healed. However, the finger was cold and white, which did not heal for a long time.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient identifier, age/dob, gender, weight, and ethnicity and race were not provided for reporting. Brand name, common device name, manufacturer name, city, and state, lot #: this report is for (band aid brand kizu power pad (kpp) 6ct ap 4901730016322 4901730016322apa 4901730016322apa). 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). Udi: (b)(4). Upc # 4901730016322, lot # 1940c. Expiration date: 06/30/2023. Concomitant medical products: device is not expected to be returned for manufacturer review/investigation. Device history records review was completed. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification. The product was manufactured on july 12, 2020. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameBAND AID BRAND KPP (KIZU POWER PAD) BANDAGES
Type of DeviceDRESSING, 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 Key14655908
MDR Text Key294662164
Report Number2214133-2022-00026
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4901730016322
Device Lot Number1940C
Was Device Available for Evaluation? No
Event Location Other
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2020
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/10/2022 Patient Sequence Number: 1
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