• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Erythema (1840); Itching Sensation (1943); Pain (1994); Rash (2033); Contact Dermatitis (4546); Eczema (4547)
Event Date 02/13/2021
Event Type  Injury  
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 kpp large 6 2013 ap 4901730021913 0037131776apa). 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). Upc #: 4901730021913, exp date: dec-01-2022, lot #: 3469c, udi #: (b)(4). Device is not expected to be returned for manufacturer review/investigation. Concomitant product: irribow (ramosetron hydrochloride), once a day, 1 tablet in the morning; miya bm (clostridium butyricum) - 3 times a day, 1 tablet at one time. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. A review of the device history records has been requested. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
A mother reported her son hit the area above his heel and got a scratch. One week after the injury, he applied band aid brand kpp (kizu power pad) bandages (kpp) to the wound because it got worse, and then he had been using the product with replacing it with a new one. One week later, he stopped using the product. On (b)(6) 2021, he started to have painful red eczema on the skin around the wound. He visited a hospital and was diagnosed with infected dermatitis due to kpp. On (b)(6) 2021, the next day, eczema started to appear also on the right thumb, and then eczema which was becoming red appeared on other areas including the arm and back. He was prescribed an ointment for treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11455178
MDR Text Key238933062
Report Number2214133-2021-00004
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 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4901730021913
Device Lot Number3469C
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/10/2021 Patient Sequence Number: 1
Treatment
IRRIBOW; MIYA BM
-
-