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

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

Patient Problems Erythema (1840); Unspecified Nervous System Problem (4426); 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 identifier, 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 381371175338 8137117533usa 8137117533usa).Lot number was not available for reporting.D4: udi, upc, lot number and expiration date are not available for reporting.D9: 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.Health effect clinical code: e2402 refers to consumer "glucose metabolism disorder and diabetes mellitus worsened¿ & amp; "intentional misuse/off-label use & quot; of the product.E171601 refers to consumer alleged ¿leg turned red & quot;.E0139 refers to consumer alleged & quot; leg had developed some kind of neurological disease¿ at this time, this event is being reported with an overabundance of caution.Medical history of prostate cancer and diabetes mellitus was noted in consumer¿s medical history.The consumer used the product for ¿almost a month from about 2 months prior to this reporting without consulting a doctor¿ (interpreted as misuse; code: e2402).It was reported that post usage of product, consumer¿s ¿diabetes mellitus worsened¿; no further details available regarding indication or location of product use.Based on limited information available event considered (interpreted as diabetes mellitus aggravated (coded to other serious or important medical event; code: e2402; causality: not related).It was also reported that the consumer¿s leg became red (coded to erythema; code: e171601; causality related) and that he had developed ¿some kind of neurological disease¿ (coded to unspecified nervous system problem; code: e0139; causality: not related).As the event of diabetes mellitus aggravated is assessed as serious; severity moderate for diabetes mellitus aggravated.Causality is related for erythema and not related for diabetes mellitus worsened & some kind of neurological disease.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An 84-year-old male consumer reported that he has prostate cancer and diabetes mellitus.Consumer reported he used band aid brand kizu power pad for almost a month from about two months prior to this reporting without consulting a doctor.Consumer reported their diabetes mellitus worsened and the consumer¿s leg turned red.Consumer reported his leg developed an unknown kind of neurological diseases.The patient is still experiencing symptoms while reporting this event.No further information was provided about this event.

• 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
• Manufacturer (Section G): COLOPLAST HUNGARY KFT; h-4300 hyirbator; coloplast u.2 ; HU
• Manufacturer Contact: michael connaughton ; 199 grandview rd; skillman, NJ 08558-9418 ; 9086555919
• MDR Report Key: 18366810
• MDR Text Key: 331014816
• Report Number: 2214133-2023-00042
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2023

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
• Event Location: Other
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Male