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

Model Number 381371172979

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

Patient Problem No Code Available (3191)

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient ethnicity and race was not provided for reporting.(b)(4).Expiration date= na.Lot number = 0579c.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.A review of the device history records has been requested.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This is one of three medwatches being submitted as three devices were involved in this event.See medwatch 2214133-2019-00100, 2214133-2019-00101& 2214133-2019-00102.The same consumer is represented in each medwatch.

Event Description

A mother called on behalf of her daughter to report an event with band aid brand hydroseal bandages all purpose.The mother used a hydro seal for a scab on her daughter.The patient had blisters all around her leg where the bandage was applied.The consumer sought medical attention and was prescribed silver sulfadiazine burn cream.The consumer is still experiencing symptoms.This is one of three medwatches being submitted as three devices were involved in this event.See medwatch 2214133-2019-00100, 2214133-2019-00101& 2214133-2019-00102.The same consumer is represented in each medwatch.

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 an 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.H6: 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.This product was manufactured on january 25, 2019.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview road; skillman NJ 08558 9418
• MDR Report Key: 8946861
• MDR Text Key: 160892193
• Report Number: 2214133-2019-00101
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 381371172979
• UDI-Public: (01)381371172979(10)0579C
• 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,Followup
• Report Date: 08/28/2019

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
• Device Model Number: 381371172979
• Device Lot Number: 0579C
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/16/2019
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 26