JOHNSON & JOHNSON CONSUMER INC BAB EXTRA LARGE BANDAGES; TAPE AND BANDAGE, ADHESIVE
|
Back to Search Results |
|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Burn(s) (1757); Erythema (1840); Skin Inflammation/ Irritation (4545)
|
Event Type
Injury
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.Patient weight, and ethnicity and race were not provided for reporting.This report is for one (1) band-aid extra large bandages unspecified usa not applicable baxlbdusunsp.Lot # and udi # are not available.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.Device history records review could not be completed without the lot number.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch (b)(4).The same patient is represented in each medwatch.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 an event with unspecified band-aid extra large bandages.The consumer had an unknown procedure performed and used the product on (b)(6) 2021.Shortly after use, the product made her skin red and irritated.Also, her skin was burning from the product and she ended up having to go to the emergency room.She was treated with injections of some steroids (unknown), given pain killer ¿toratol¿ and an unknown antibiotic.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch (b)(4).The same patient 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.Additional information data: b5 b7 this is 1 of 2 supplemental med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2021-00020.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Based on additional information received on july 9, 2021.The consumer's symptoms improved after stopping use of the product and was not experiencing the symptoms while reporting this event.This is 1 of 2 supplemental med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2021-00020.The same patient is represented in each medwatch.
|
|
Search Alerts/Recalls
|
|
|