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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 4901730021913
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Blister (4537)
Event Type  Injury  
Manufacturer Narrative
Patient information was not provided for reporting. This report is for (band aid brand kizu power pad (kpp) large 6ct ap (b)(4)). 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 (b)(4)). Udi #:(b)(4), upc #: (b)(4). Device is not expected to be returned for manufacturer review/investigation 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 (b)(4)). 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 reported about his/her spouses event with a band aid brand kpp (kizu power pad) bandages. On (b)(6) 2021, the consumer applied kpp to a blister on the back of his/her thigh. The cause of the blister was unknown. After that, the consumer stated that the blister was getting bigger and flabby, and the application area around the blister became itchy. At the time of this reporting ((b)(6) 2021), the consumer visited a hospital. Since the reporter had used kpp for a burn blister and it healed, the reporter thought kpp could be used for the consumers blister. The consumer is still experiencing symptoms.
 
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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 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 Key12380130
MDR Text Key268681882
Report Number2214133-2021-00037
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 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4901730021913
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/27/2021 Patient Sequence Number: 1
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