Device was used for treatment, not diagnosis.Upc #: 381371150786, lot #: 201114, expiration date: na, udi #: (b)(4).Device is not expected to be returned for manufacturer review/investigation.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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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 november 14, 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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