Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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Jada system did not work [device ineffective].Case narrative: this spontaneous report originating from united states was received from an unspecified physician via clinical account specialist (cas), referring to a female patient of unknown age.The patient's medical history, current conditions, past drugs/ allergies and concomitant medications were not reported.At the time of reporting, the patient was not pregnant.This report concerns 1 patient and 1 device.The physician reported that her colleagues (unspecified) stated that on an unknown date, there was an instance when the patient was inserted with vacuum-induced hemorrhage control system (jada system), intravaginally for postpartum hemorrhage, by an unspecified healthcare provider, however, the vacuum-induced hemorrhage control system (jada system) did not work (device ineffective) and her healthcare provider had to use surgical interventions (unspecified).Reportedly, the patient sought medical attention.No further details were available at the time of reporting.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.Upon internal review, the event of device ineffective was considered to be serious due to required intervention.This was one of the six reports received from the same reporter.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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Manufacturer Narrative
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Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.
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Event Description
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Jada system did not work [device ineffective].Difficulty with placing jada [device difficult to use].Case narrative: this spontaneous report originating from united states was received from an physician via clinical account specialist (cas), referring to a non-pregnant female patient of unknown age.The patient's medical history, current conditions, past drugs/ allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.The physician reported that her colleagues (unspecified) stated that on an unknown date, there was an instance when the patient was inserted with vacuum-induced hemorrhage control system (jada system), intravaginally for postpartum hemorrhage (postpartum haemorrhage), by an unspecified healthcare provider, however, the vacuum-induced hemorrhage control system (jada system) did not work (device ineffective) and her healthcare provider had to use surgical interventions (unspecified).Reportedly, the patient sought medical attention.No further details were available at the time of reporting.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), the lot number and the serial number were not available.Upon internal review, the event of device ineffective was considered to be serious due to required intervention.This was one of the six reports received from the same reporter.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).Follow up information was received from the physician (also reported as "nurse manager") via sales contractor on 21-jul-2023.The caller stated that the vacuum-induced hemorrhage control system (jada system) had difficulty with placing (device difficult to use) and sales contractor talked through some troubleshooting and recommended using traction on the anterior cervical lip.No additional information provided.
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Manufacturer Narrative
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Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.
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Search Alerts/Recalls
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