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 Hemorrhage/Bleeding (1888); Itching Sensation (1943); Skin Tears (2516); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

A consumer had been using band aid brand kpp (kizu power pad) bandage on his/her painful areas due to gout (soles and sides of feet) since about (b)(6) 2021.When the consumer removed the strip without soaking it in hot water, the skin peeled off extensively with it, so the consumer applied a new strip again.The consumer had continued to use kpp since then while replacing the strip, but sometimes clots of blood were noted on the strip when the consumer removed it.At the time of this reporting ((b)(6) 2022), the affected area was swollen and the fingertips around the area where the strip was applied were itchy.The consumer¿s toes did not touch the floor and could not walk.He was told by attending physician to see a dermatologist.

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 (b)(4)).Lot number is not available.Concomitant medical products: device is not expected to be returned for manufacturer review/investigation.Udi: (b)(4).Upc: 4901730080156.Lot number is not available.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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; 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: 13455752
• MDR Text Key: 289274872
• Report Number: 2214133-2022-00002
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730080156
• UDI-Public: (01)4901730080156(10)NI
• 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: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention