Provider performed a "very vigorous fundal massage and the jada device came out of the patient with the balloon still intact [device expulsion] case narrative: this initial spontaneous report originating from the united states, was received from a clinical educator via clinical account specialist (cas), referring to a non-pregnant female patient.The patient's medical history included pregnancy and delivery.Her concurrent conditions, past drugs/allergies, and concomitant medications were not reported.The patient had lost 2100 cc of blood at delivery prior to use of vacuum-induced hemorrhage control system (jada system).This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient underwent vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiry date were not reported) placement by the provider for postpartum hemorrhage.It was reported that the suction was on and working and the canister was filling.The provider performed a "very vigorous fundal massage and the vacuum-induced hemorrhage control system (jada system) device came out of the patient with the balloon still intact" (device expulsion).The patient sought medical attention and ended up with a hysterectomy.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.Upon internal review, the event of device expulsion was determined to be serious due to the following reasons: medically significant and required intervention.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.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed).
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