MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND HYDROSEAL BANDAGES HEEL; DRESSING, WOUND, OCCLUSIVE

Model Number 381371174195

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient ethnicity and race was not provided for reporting.(b)(4).Lot #:1669c; exp date: ni.Device is not expected to be returned for manufacturer review/investigation device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on feb-25-2019.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer reported she had a mosquito bite that turned into a blister.Doctor recommended the consumer to put a band aid brand hydroseal bandages heel on and follow the directions.However, the blister got infected.The consumer sought medical attention from urgent care.The health care professional recommended that the consumer not to use the blister band aid because the blister should breathe.Additionally, the health care professional had also cleaned the blister.

• Brand Name: BAND AID BRAND HYDROSEAL BANDAGES HEEL
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): COLOPLAST A/S; holtedam 1; hovedsaden DK-30 50; DA DK-3050
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 9292258
• MDR Text Key: 179118242
• Report Number: 2214133-2019-00127
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 381371174195
• UDI-Public: (01)381371174195(10)1669C
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381371174195
• Device Lot Number: 1669C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 66