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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 Anaphylactic Shock (1703); Urticaria (2278)
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Patient weight and ethnicity were not available for reporting. This report is for (band aid brand kizu power pad unspecified ap notapplicable 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 1ct usa 381371175338 8137117533usa). Product is unspecified and lot number was not provided. 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. If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.
 
Event Description
Consumer applied band aid brand kizu power pad ap 051713ap for treatment of the wound and reported urticaria after application. The symptoms of urticaria became worse with each time, and in march, she experienced anaphylaxis. Consumer stated the cause of the urticaria was not known at the time of her initial consultation with physician. Consumer sought medical consultation for treatment. It was reported that, consumer symptoms improved after stopped using the product. Consumer was not experiencing any symptoms while reporting this event.
 
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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
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key12365474
MDR Text Key268063993
Report Number2214133-2021-00033
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,Followup
Report Date 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
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 Received09/02/2021
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: 08/25/2021 Patient Sequence Number: 1
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