MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. BAND AID BRAND HYDROCOLLOID MOON; DRESSING, WOUND, OCCLUSIVE

Model Number 4901730120012

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

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/12/2022

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 hydrocolloid moon 10ct ap 4901730120012 4901730120012apa 4901730120012apa).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: 4901730120012.Lot number is not available; exp date is na.Device is not expected to be returned for manufacturer review/investigation.(b)(4).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 additional information becomes available.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 reported an event with band aid brand hydrocolloid moon 10ct (kpp).On (b)(6)2022 the consumer replaced the kpp that was placed on chapped skin.The consumer removed the kpp and bleeding persisted.The consumer washed the affected area with water, applied a new kpp, and secured it with tape (other manufacture¿s product).On (b)(6) 2022, the consumer visited his/her physician.The health care professional removed the tape (other manufacture¿s product), examined the kpp, and told the consumer to keep it applied to the affected area until next visit to the hospital.A nurse of the hospital secured the kpp with a medical tape.

• Brand Name: BAND AID BRAND HYDROCOLLOID MOON
• 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: 13758096
• MDR Text Key: 289352310
• Report Number: 2214133-2022-00011
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 4901730120012
• UDI-Public: (01)4901730120012
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730120012
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/17/2022
• 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