|
It was reported a patient underwent an unknown procedure on an unknown date in 2026 and a drain was used.In the (b)(6) post surgery, the patient was cleaning the outside of the drain, by wiping it down the length and the end snapped off.It snapped off nearer to the wound.Drain was discarded and replaced with other.A sample is available, not original.Additional information has been requested.
|
|
Product complaint # (b)(4)
additional information:
d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information provided:
did the event happen during a procedure? no this was in the (b)(6) post surgery.Were you in the procedure at the time of the event? no.Was the product being used in a clinical trial? no.Event outcome/how was it managed? drains replaced in patients.Has the reporter facility indicated there may be legal action? no.The product available for return? not the originals from when both incidents happened, but one from each of the same batch from theatres.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Procedure name?
please provide the date of procedure?
date of event where product had an issue?
were there any intra-operative complications? if so, what were they?
where was the tip of drainage tube located?
how was the drain secured?
was another product used?
please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure
the diagnosis and indication for the index surgical procedure?
were any concomitant procedures performed?
was a piece of drain retained in the patient?
if yes, when was the drain piece removed and describe how?
when was the 2nd procedure performed and replaced with a new drain?
other relevant patient history/concomitant medications?
what is the physician¿s opinion as to the etiology of or contributing factors to this event?
what is the patient's current status?
surgeon¿s name?
if applicable, will product be returned? if so, please provide the return date and tracking information.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.
|
