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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM
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ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
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
Jada had failed due to multiple factors, macroscomic baby, jada pulled out, patient went for hysterectomy [device ineffective].Case narrative: this initial spontaneous report was received from a nurse via clinical educator (ce) at the hospital, referring to a female patient of unknown age.The patient¿s concomitant medications, and drug reactions/allergies were not reported.The patient¿s medical history included pregnancy and had delivered macroscomic baby.The patient¿s concurrent conditions included uterine atony.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (1 device) for abnormal postpartum uterine bleeding or hemorrhage (postpartum haemorrhage).It was reported that the vacuum-induced hemorrhage control system (jada system) had failed due to multiple factors, macroscomic baby (device ineffective).The vacuum-induced hemorrhage control system (jada system) was pulled out (removed) and the patient had the hysterectomy as an escalating treatment to control the abnormal postpartum uterine bleeding or hemorrhage.It was reported that the patient sought medical attention.The reporter had no additional information regarding about what failed for the vacuum-induced hemorrhage control system (jada system) during use.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.Upon internal review, the event of device ineffective was considered to be serious due to required intervention.Medical device reporting criteria: serious injury.(b)(4).
 
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
Jada had failed due to multiple factors, macroscomic baby, jada pulled out, patient went for hysterectomy/staff hooked the jada system back up but the hospital¿s suctioning system failed [device ineffective] case narrative: this initial spontaneous report was received from a nurse (also reported as clinical educator (ce) at the hospital) via company representative (also reported as ce), referring to a female patient of unknown age.The patient¿s concomitant medications, and drug reactions/allergies were not reported.The patient¿s medical history included pregnancy and had delivered macroscomic baby.The patient¿s concurrent conditions included uterine atony.This report concerns 1 patient and 1 device.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (1 device) for abnormal postpartum uterine bleeding or hemorrhage (postpartum haemorrhage).It was reported that the vacuum-induced hemorrhage control system (jada system) had failed (device ineffective) due to multiple factors, macroscomic baby.The vacuum-induced hemorrhage control system (jada system) was pulled out (removed) and the patient had the hysterectomy as an escalating treatment to control the abnormal postpartum uterine bleeding or hemorrhage.It was reported that the patient sought medical attention.The reporter had no additional information about what failed for the vacuum-induced hemorrhage control system (jada system) during use.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not available.Upon internal review, the event of device ineffective was considered to be serious due to required intervention.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).Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan).Follow up information was received from nurse via company representative (clinical account specialist (cas) (previously reported as ce) on 30-jan-2023.It was stated that the vacuum-induced hemorrhage control system (jada system) initially worked and during the observation period, the patient began bleeding again.The staff hooked the vacuum-induced hemorrhage control system (jada system) back up but the hospital¿s suctioning system failed and the patient continued bleeding and had to undergo a hysterectomy.No additional adverse event (ae) or product quality complaint (pqc) identified.Fda code: (health effects - health impact per annex f): 2199 (no apparent harm occurred in relation to the adverse event.).This report is being downgraded due to that it is no longer serious injury.
 
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Brand Name
JADA SYSTEM
Type of Device
INTRAUTERINE VACUUM CONTRACTION SYSTEM
Manufacturer (Section D)
ORGANON & CO.
30 hudson street
jersey city NJ 07302
Manufacturer (Section G)
ORGANON & CO.
30 hudson street
jersey city NJ 07302
Manufacturer Contact
30 hudson street
jersey city, NJ 07302
MDR Report Key16026042
MDR Text Key305924576
Report Number3002806821-2022-00028
Device Sequence Number1
Product Code OQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510K K201199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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