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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KIZU POWER PAD DRESSING, WOUND, OCCLUSIVE Back to Search Results
Model Number 4901730021906
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Eczema (4547)
Event Date 07/05/2021
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient identifier, age at time of event, gender, weight, and ethnicity and race were not provided for reporting. This report is for (band aid brand kizu power pad regular ap 4901730021906 0037131785apa). 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). Udi - (b)(4). Upc - 4901730021906. Lot number and expiration date - ni. Device is not expected to be returned for manufacturer review/investigation this report is for (band aid brand kizu power pad regular ap 4901730021906 0037131785apa). 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). 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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
A consumer got a wound on the back of hand and applied band-aid brand kizu power pad (kpp). When the consumer removed the kpp on (b)(6) 2021, white itchy eczema appeared on the application site. The consumer stopped using the product. The consumer's symptoms did not improve after stopping use of the product and was still experiencing the symptoms while reporting this event. The consumer visited hospital for treatment. No further information regarding patient information was provided.
 
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Brand NameBAND AID BRAND KIZU POWER PAD
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 Key12177644
MDR Text Key261836236
Report Number2214133-2021-00027
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4901730021906
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/15/2021 Patient Sequence Number: 1
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