|
Model Number 381370044246 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Burn(s) (1757); Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 03/08/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.Weight and ethnicity were not provided for reporting.This report is for (bab tough strips extra large 10s usa 381370044246 8137004424usa 8137004424usa).Udi #: (b)(4).Upc #: 381370044246, expiration date: na,lot #: 191130.Concomitant medical products: 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 november 30, 2019.If information is obtained that was not available for the initial medwatch, an additional follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Consumer reported an event with band-aid tough strips extra large.Consumer reported that on (b)(6) 2021 she used the product to cover a pimple on her leg so that her paints would not irritate it.Within an hour or two, the consumer started having intense soreness on her leg.The consumer removed the product and alleged a chemical burn.Consumer stated that she was burned so badly that it had puss and a little blood at the site.The consumer sought medical attention from a health care professional (hcp).Her hcp prescribed antibiotic topical (apply the topical twice daily until the pus stops and the wound heals), told her to cover it with gauze and wrap her leg with a bandage.On (b)(6) 2021, the symptoms resolved.
|
|
Search Alerts/Recalls
|
|
|