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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Scarring (2061); Swelling (2091); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. This report is for (band aid brand kizu power pad unspecified ap). 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 (b)(4). Lot # is not available. Udi # is not available, as product is unspecified. 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). 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). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
A female consumer had been using kpp to the wound on her wrist for about a month until the beginning of (b)(6) 2020. About 2 weeks had passed since she stopped using the product, the wound became red and swelled. Thus, she visited a hospital and was told that it had become keloid. On (b)(6) 2020, an ointment was prescribed for keloid at the hospital. Although the keloid would be observed for a while, she was told that keloid would not be completely cured. She used the product because the product was described as the wound would cure cleanly. The consumer stated that the wound became severe. The consumer is still experiencing symptoms.
 
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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 hungry kft.
h-4300 nyirbator
coloplast u.2
HU
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key9861311
MDR Text Key196584516
Report Number2214133-2020-00010
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 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/25/2020
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: 03/20/2020 Patient Sequence Number: 1
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