Jada was used, and it wasn't successful [device ineffective] no other ae reported, no pqc reported [no adverse event] case narrative: this spontaneous report originating from united states was received from physician via clinical sales educator referring to a female patient of unknown age.The patient's medical history, past drugs or allergies, and concomitant medications were not reported.This report concerns 1 patient(s) and 1 device(s).On an unknown date, the patient was inserted with the vacuum-induced hemorrhage control system (jada system) via vaginal route (batch/lot# and expiry date were not reported) for an unknown indication.The clinical sales educator reporting on behalf of the physician.On 01-feb-2024, the clinical sales educator reported that she was speaking with the safety officer of the facility.The clinical sales educator reported the safety officer said she saw in a chart review that a vacuum-induced hemorrhage control system (jada system) was used, and it was not successful (device ineffective), so it was taken out and vaginal packing was used.The clinical sales educator reported there was no mention that they believed there was an issue with the product itself.She had a contact number for the safety officer (see case contacts) but did not have confirmed contact information for the physician.The patient sought medical attention.She had no further information to provide.No other adverse event (ae) or product quality complaint (pqc) reported (no adverse event).Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn.The outcome of device ineffective was unknown.Upon internal review, the event device ineffective was determined to be medically significant.Medical device reporting criteria: serious injury when the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Fda code: (health effects - health impact per annex f): 4648 insufficient information (it is not clear whether any health impact occurred, or health impact appears to have occurred, but there is not yet enough information available to classify the health impact).
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