MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. BAND AID BRAND SHEER BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number 4901730020060

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

Patient Problems Peeling (1999); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight and ethnicity were not provided for reporting.This report is for band aid brand sheer wide 20 ap 4901730020060 3720612903apa.Device is not distributed in the united states.Band aid brand sheer wide 20 ap 4901730020060 3720612903apa.3720612903apa is similar to device marketed in the usa (bab sheer 1inx3in usa 38137004770 8137004770usa 8137004770usa).Udi #: (b)(4).Upc #: 4901730020060.Lot #: 200116.Exp: na.Device is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa (bab sheer 1inx3in usa 38137004770 8137004770usa 8137004770usa).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.If information is obtained that was not available for the initial medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

A (b)(6)-year-old male consumer complained that his skin was peeled off with strong adhesion of band-aid sheer wide when he removed the product.He felt abnormal with the product because such symptom never occurred with band-aid sheer wide he bought 2 or 3 months before.He applied a medication prescribed at a dermatology department and attached band-aid to the peeled skin.

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.H4, 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.The product was manufactured on january 16, 2020.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: BAND AID BRAND SHEER BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.; 199 grandview road; skillman NJ
• MDR Report Key: 11982137
• MDR Text Key: 255616696
• Report Number: 1000599868-2021-00009
• Device Sequence Number: 1
• Product Code: KGX
• 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,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4901730020060
• Device Lot Number: 200116
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 06/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR