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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Local Reaction (2035); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
It was reported that the male consumer got a small wart on his forearm and burned it by himself with burning moxa. After that, the consumer disinfected it with oxydol and treated it with makiron, benzethonium chloride, allantoin, chlorpheniramine maleate, and an ointment. Two weeks later, it was not improved much, so the consumer applied band aid brand kizu power pad (kpp) for wound care. The wound became purulent and was not recovered, so the consumer went to a dermatology clinic and applied the prescribed gentamicin, gentamicin sulfate, and then kpp on it. The wound was being recovered recently, but there was a line in the middle of the wound. The patient is still experiencing symptoms. This is 2 of 2 med-watches being submitted as two devices were involved in this event. See medwatch 2214133-2022-00004. The same patient is represented in each medwatch.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient identifier, weight, and ethnicity and race were not provided for reporting. This report is for (band aid brand kizu power pad unspecified ap not applicable rgebabkapa rgebabkapa). Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1 ct usa 381371175338 8137117533usa 8137117533usa). Udi, upc and lot number are not available. Device is not expected to be returned for manufacturer review/investigation. 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. (b)(4). This is 2 of 2 med-watches being submitted as two devices were involved in this event. See medwatch 2214133-2022-00004. 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.
 
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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 hyirbator
coloplast u.2
HU
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key13670926
MDR Text Key290797091
Report Number2214133-2022-00005
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 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Event Location Other
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 03/04/2022 Patient Sequence Number: 1
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