MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KIZU POWER PAD; DRESSING, WOUND, OCCLUSIVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient identifier, age at time of event, weight, and ethnicity and race were 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 (b)(4)).Udi# is not available.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.There are 4 med-watches being submitted as similar events were reported based on initial reporter's event.The same symptoms were represented in each medwatch.2214133-2021-00008 represents the case for a consumer who came to the reporter¿s hospital after applying kpp to a burn wound twice, 2214133-2021-00007 represents the case of an adult female with same issues; 2214133-2021-00009 represents the case of the (b)(6) year-old girl with same issues; and 2214133-2021-00010 was created to represent the reporter¿s report that he/she had previously seen other patients (in addition to the noted 3) who had the similar symptoms.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Dermatologist reported that many patients (consumers) who applied kpp to burn wounds came to his/her clinic recently.According to the reporter, the consumers seemed not to have understood severity of their burn wounds and felt pain when removing kpp.Also, product was not effective and made the wound worse.Consumer was admitted to hospital.There are 4 med-watches being submitted as similar events were reported based on initial reporter's event.The same symptoms were represented in each medwatch.2214133-2021-00008 represents the case for a consumer who came to the reporter¿s hospital after applying kpp to a burn wound twice, 2214133-2021-00007 represents the case of an adult female with same issues; 2214133-2021-00009 represents the case of the (b)(6) year-old girl with same issues; and 2214133-2021-00010 was created to represent the reporter¿s report that he/she had previously seen other patients (in addition to the noted 3) who had the similar symptoms.

• Brand Name: BAND AID BRAND KIZU POWER PAD
• Type of Device: DRESSING, 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 Key: 11486465
• MDR Text Key: 250421783
• Report Number: 2214133-2021-00007
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention