Device was used for treatment, not diagnosis.Dob: (b)(6); patient weight, and ethnicity and race were not provided for reporting.Udi #: (b)(4).Upc #: 381370056591.Lot #: 2110b.Expiration 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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A (b)(6) year old female consumer reported an event with bab clear water block plus 30s usa 381370056591.The consumer applied the product for the first time to a little scrape that she had on the back of her hand, just below her wrist.The consumer reported the adhesive was very sticky and her skin peeled off about a size of a silver dollar.Consumer stated she has thin skin.Consumer reported that she was transported by ambulance to the hospital because of her fractured back (unrelated to the product).At the hospital, to treat the fractured back, the wound was also treated.The nurse removed the band-aid because it had bled and redressed it.It took about half an hour to remove the band-aid.Consumer reported that the nurse put a dressing and cured it.Consumer had to keep the hand under water and reported painful experience due to this event.Consumer also stated that the wound is larger.Consumer had applied an antibiotic and dressing for treatment.
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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 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 july 29, 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.
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