Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 11/10/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Did not control the bleeding [device ineffective] case narrative: this spontaneous report originating from united states was received from a consumer via clinical educator (ce), referring to a 21-year-old female patient.The patient's concurrent conditions included postpartum hemorrhage.The concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On unknown date, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage indication.On (b)(6) 2023, the patient experienced postpartum hemorrhage after delivery, sought medical attention that none of the medications administered worked (medications given were unknown), vacuum-induced hemorrhage control system (jada system) was inserted but did not control the bleeding (device ineffective), and care was escalated to hysterectomy.The patient was not doing well.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 as serious due to the 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.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Did not control the bleeding [device ineffective].Case narrative: this spontaneous report originating from united states was received from a consumer via clinical educator (ce), referring to a 21-year-old non pregnant female patient.The patient's concurrent conditions included postpartum hemorrhage.The concomitant medications and past drug reactions/allergies were not reported.This report concerns 1 patient and 1 device.On (b)(6) 2023, the patient underwent insertion with vacuum-induced hemorrhage control system (jada system) via intravaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage indication.On (b)(6) 2023, the patient experienced postpartum hemorrhage after delivery that none of the medications administered worked (medications given were unknown), vacuum-induced hemorrhage control system (jada system) was inserted but did not control the bleeding (device ineffective), and care was escalated to hysterectomy.The patient was not doing well.The patient sought medical attention.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 as serious due to the 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, including percutaneous or minimally invasive procedures, were required, or an existing procedure changed).This is an amended report to check product problem checkbox.
|
|
Search Alerts/Recalls
|
|