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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 4901730080156
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Itching Sensation (1943); Skin Tears (2516); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
A consumer had been using band aid brand kpp (kizu power pad) bandage on his/her painful areas due to gout (soles and sides of feet) since about (b)(6) 2021. When the consumer removed the strip without soaking it in hot water, the skin peeled off extensively with it, so the consumer applied a new strip again. The consumer had continued to use kpp since then while replacing the strip, but sometimes clots of blood were noted on the strip when the consumer removed it. At the time of this reporting ((b)(6) 2022), the affected area was swollen and the fingertips around the area where the strip was applied were itchy. The consumer¿s toes did not touch the floor and could not walk. He was told by attending physician to see a dermatologist.
 
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 kkp jumbo 3ct (b)(4)). Lot number is not available. Concomitant medical products: device is not expected to be returned for manufacturer review/investigation. Udi: (b)(4). Upc: 4901730080156. Lot number is not available. 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.
 
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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 nyirbator
coloplast u.2
HU
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key13455752
MDR Text Key289274872
Report Number2214133-2022-00002
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 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4901730080156
Was Device Available for Evaluation? No
Event Location Other
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes

Patient Treatment Data
Date Received: 02/04/2022 Patient Sequence Number: 1
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