JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND TRU STAY SHEER BANDAGES / SHEER; TAPE AND BANDAGE, ADHESIVE
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Model Number 381370047681 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Skin Tears (2516); Partial thickness (Second Degree) Burn (2694)
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Event Date 10/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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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 and 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.This report is for one (1) band-aid brand tru stay sheer large adhesive pad 10ct usa 381370047681 381370047681usa 381370047681usa, lot number 3201b.Udi #: (b)(4).Upc #: 381370047681, lot #: 3201b and 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.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Consumer reported an event with band-aid brand tru stay sheer large adhesive pad.Consumer had a wound and she used the bandage on (b)(6) 2022.On (b)(6) 2022, the band-aid took the skin off of her.There was a wound underneath the part where it was covered, but it took the skin off.The consumer sought medical attention and the health care professional (hcp) stated it was a second degree burn.The symptoms did not improve after the patient stopped using the product and was still experiencing symptoms.It was reported that the hcp prescribed unknown antibiotics for the treatment.
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Manufacturer Narrative
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Johnson & amp; 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 & amp; 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 & amp; johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & amp; 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 november 16, 2021.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow- up medwatch will be filed as appropriate.
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