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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
Model Number 4901730080156
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Scar Tissue (2060); Impaired Healing (2378); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Johnson & johnson consumer, inc. Is submitting this report pursuant to the provisions of 21 cfr, part 803. This report may be based on information which johnson & johnson consumer, inc. Has not been able to investigate or verify prior to the required reporting date. This report does not reflect a conclusion by fda, johnson & johnson consumer, inc. Or its employees that the report constitutes and admission that the device, johnson & johnson consumer, inc. , or its employees caused or contributed to the potential event described in this report. Device was used for treatment, not diagnosis. Patient information was 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 1ct usa 381371175338 8137117533usa 8137117533usa ). Device is not expected to be returned for manufacturer review/investigation. 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 1ct usa 381371175338 8137117533usa 8137117533usa ). 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 1 of 2 med-watches being submitted as two devices were involved in this event. See medwatch 2214133-2021-00031 for band aid brand kizu power pad plus. 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.
 
Event Description
A consumer got a scratch wound on the consumer¿s knee and used band aid brand kizu power pad/band aid brand kizu power pad plus for the wound. The consumer replaced the products with a new one every few days according to the instructions and continued to use them for several weeks. Since it was stated that the products would be ineffective if the wound dried, the consumer stopped using them when the wound dried. After a few days, the wound looked like a scab with skin on it. Even after a few weeks, there was no change from that condition. The consumer was worried about it and visited a hospital. A doctor stated that surgery would be necessary if the condition remained and prescribed an ointment to improve blood circulation in the blood that had set in the wound. According to the doctor, the wound was too deep and the products might not have been able to heal the wound completely. The consumer did not think the depth of the wound when using the product or the possibility of this from happening was specified in the package insert. The consumer used 2 kinds of band-aids. Band aid brand kizu power pad/band aid brand kizu power pad plus for the wound. This is 1 of 2 med-watches being submitted as two devices were involved in this event. See medwatch 2214133-2021-00031 for band aid brand kizu power pad plus. The same patient is represented in each medwatch.
 
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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 hungary kft.
h-4300 nyirbator
coloplast u.2
HU
Manufacturer Contact
laurie rauco
199 grandview rd
skillman, NJ 08558-9418
2152734905
MDR Report Key12252669
MDR Text Key266680085
Report Number2214133-2021-00030
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,Followup
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
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
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/16/2021
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: 07/30/2021 Patient Sequence Number: 1
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