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

Model Number 4901730077002

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

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 08/21/2019

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 large 12ct ap 4901730077002 0037131787apa 0037131787apa).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 # is not available.Udi # (b)(4); lot number = ni; exp date: na.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.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).(b)(4).This is one of five medwatches being submitted as five devices were involved in this event.See medwatch 2214133-2019-00108 (band-aid 01), 2214133-2019-00110 (band-aid 03), 2214133-2019-00111 (band-aid 04) and 2214133-2019-00112 (band-aid 05).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

One week prior to the day of this reporting, a male consumer got a scratch.He consulted with a pharmacist and was recommended kpp.The affected area swelled white after he started using kpp on (b)(6) 2019, but the skin of the area had not regenerated yet.He had used 5 strips of kpp at the time of this reporting.He stated that a discharge of pus and bleeding occurred on the affected area after he replaced the kpp with a new one.He consulted with a physician, who prescribed terra-cortril.As of this reporting, he was applying terra-cortril to the affected area twice a day.The outcome of the event was unknown.This is one of five medwatches being submitted as five devices were involved in this event.See medwatch 2214133-2019-00108 (band-aid 01), 2214133-2019-00110 (band-aid 03), 2214133-2019-00111 (band-aid 04) and 2214133-2019-00112 (band-aid 05).The same patient is represented in each medwatch.

• Brand Name: BAND AID BRAND KIZU POWER PAD AP
• 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: 9087458
• MDR Text Key: 163546441
• Report Number: 2214133-2019-00109
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730077002
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 08/23/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention