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

Model Number 4901730080156

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

Patient Problems Scar Tissue (2060); Impaired Healing (2378); 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, gender, weight, and ethnicity and race were not provided for reporting.This report is for (band aid brand kkp jumbo 3ct ap 4901730080156 4901730080156apa 4901730080156apa).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).Udi #: (b)(4), upc - 4901730080156, lot number - ni, expiration date - ni.Device is not expected to be returned for manufacturer review/investigation.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).Two medwatches (2214133-2021-00039 & this report) are being submitted as two devices (band aid brand kizu power pad plus & band aid brand kizu power pad jumbo) were involved in this event.See medwatch 2214133-2021-00039.The same patient is represented in each medwatch.It should be noted, that this submission is potentially the same event/consumer that was submitted under medwatch 2214133-2021-00030 for band aid brand kizu power pad and 2214133-2021-00031 for band aid brand kizu power pad plus.The same patient is represented in each one of those medwatches.Although the events are very similar in nature and this event is a second-hand source as an employee referring to a social media review, it cannot be determined conclusively that these are the same consumer.Therefore, these two medwatches will be submitted out of an abundance of caution and will be treated as independent submissions and complaints.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported that he/she fell while jogging and got a scratch wound.On the day of injury, he/she purchased kpp plus at a drug store and used it following the instruction.After he/she used up kpp plus, he/she started using kpp jumbo.About 2 weeks after that, the wound became dry.He/she stopped using kpp because the instruction mentioned not to use it after a wound became dry.After he/she left the wound as it was for a week, the wound looked like a scab with skin on it.He/she observed it for a while, but it did not heal.Therefore, he/she saw a physician.He/she was told by the physician that it was quite dangerous to leave the wound as it was.He/she was instructed by the physician to apply an ointment to improve blood circulation and was told that a surgery would be needed if it did not heal.As of this reporting, 2 and a half months had passed since he/she got the wound and about a month had passed since he/she started applying the ointment.However, the wound did not have a sign of healing.He/she was told that a surgery might be needed if the condition of the wound remained unchanged and that a scar would remain for a lifetime when the surgery was performed.According to him/her, the physician stated that the wound might have been too deep to treat with kpp.The symptoms did not improve after product was last used and consumer was still experiencing symptoms while reporting this event.Two medwatches (2214133-2021-00039 & this report) are being submitted as two devices (band aid brand kizu power pad plus & band aid brand kizu power pad jumbo) were involved in this event.See medwatch 2214133-2021-00039.The same patient is represented in each medwatch.It should be noted, that this submission is potentially the same event/consumer that was submitted under medwatch 2214133-2021-00030 for band aid brand kizu power pad and 2214133-2021-00031 for band aid brand kizu power pad plus.The same patient is represented in each one of those medwatches.Although the events are very similar in nature and this event is a second-hand source as an employee referring to a social media review, it cannot be determined conclusively that these are the same consumer.Therefore, these two medwatches will be submitted out of an abundance of caution and will be treated as independent submissions and complaints.

• Brand Name: BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• MDR Report Key: 12411702
• MDR Text Key: 280607265
• Report Number: 2214133-2021-00040
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730080156
• UDI-Public: (01)4901730080156
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730080156
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/01/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention