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

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.

Event Description

Based on additional information received from consumer on (b)(6) 2021, it was reported that the scar may remain for a lifetime and may need surgery.As of this reporting, she was applying heparin z ointment (heparin sodium) to improve blood circulation in the blood that had set in the wound and observing the wound.It had been about a month and a half since she visited the hospital, the wound was a little lighter in color, but it was still dusky-red and swollen.It was not a deep wound where muscles, tendons and bones could be seen.She applied the products to the wound after completely stopping bleeding.She had the symptom even though she used the products according to the instructions.The doctor said it was due to the use of the product on the deep wound.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 follow-up (01) 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.

Manufacturer Narrative

Johnson & amp; 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 & amp; 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 & amp; johnson consumer, inc.Or its employees that the report constitutes and admission that the device, johnson & amp; johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Updated information: udi: (b)(4), upc: 4901730080156, lot number: ni, expiration date: ni.Corrected data: d1, d2, d3, d4: 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).This is 1 of 2 follow-up (01) 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 follow-up (01) medwatch, a follow-up medwatch will be filed as appropriate.

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.Additional information: b5: h6: health effect clinical code: e2402 ¿ refer to consumer alleged about, injury worsened and dry skin.Two medwatches are being submitted as two devices were involved in this event.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 medwatch.Two additional medwatches (2214133-2021-00039 & 2214133-2021-00040) are being submitted as two devices (band aid brand kizu power pad plus & band aid brand kizu power pad jumbo).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 medwatches (2214133-2021-00039 & 2214133-2021-00040).Although the events are very similar in nature and the one 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 four 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 follow-up (02) medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

When a consumer used kpp for a scratch that he/she got while jogging, it worsened, which might require a surgery.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 are being submitted as two devices were involved in this event.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 medwatch.Two additional medwatches (2214133-2021-00039 & 2214133-2021-00040) are being submitted as two devices (band aid brand kizu power pad plus & band aid brand kizu power pad jumbo).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 medwatches (2214133-2021-00039 & 2214133-2021-00040).Although the events are very similar in nature and the one 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 four medwatches will be submitted out of an abundance of caution and will be treated as independent submissions and complaints.

• 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
• MDR Report Key: 12252669
• MDR Text Key: 266680085
• Report Number: 2214133-2021-00030
• 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,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• 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
• Date Manufacturer Received: 08/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR