They could not get the suction to work/ they could not achieve suction with the product / did not know if it was a product quality problem [device issue] did not know if it was a product quality problem or an error in the set up of the device [wrong technique in device usage process] case narrative: this spontaneous report originating from united states was received from a director of labor and delivery via company representative, referring to a female patient of unknown age.The patient's concurrent conditions, concomitant medications and drug reactions / allergies were not reported.The patient's medical history included: on an unknown date, the patient became pregnant (pregnancy) and had delivery.This report concerned 1 patient and 1 device.On an unknown date in (b)(6) 2022 (reported as one week ago), the patient underwent vacuum-induced hemorrhage control system (jada system) placement via vaginal route (lot# and expiration date were not reported) for postpartum hemorrhage (postpartum haemorrhage) by an unknown provider.The provider reported that the device / product vacuum-induced hemorrhage control system (jada system) did not achieve the suction (also reported as did not get the suction to work) and they did not know if it was a product quality problem (device issue) or an error in the set-up of the device (wrong technique in device usage process).The company representative would be going for a face to face visit next week (in (b)(6) 2022) to hospital to obtain more details.No patient or device information was known at the time of this report.The provider¿s name was unknown, at the time of this report.No other adverse event (ae) or product quality complaint (pqc) reported at this time.For vacuum-induced hemorrhage control system (jada system), the serial number was not available.Upon internal review, device issue was determined to be medically significant.Medical device reporting criteria: serious injury.(b)(4).
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