Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? no product available for return.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
|
It was reported a patient underwent a port insertion for chemotherapy on (b)(6) 2024 and topical skin adhesive was used.Patient reports that she notices the wound is slightly red and has a small rash with a fever on (b)(6) and was started on 1% hydrocortisone cream.On 2/5, it began spreading and her hydrocortisone was increased to 2.5% and was also started on aristocort cream.Patient states that on (b)(6) she was started on antibiotic and surgeon suggested to remove the port a cath on (b)(6) but patient refused.(b)(6), patient saw a dermatologist and was started on clobetasol.Additional information has been requested.
|