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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 Problems Hemorrhage/Bleeding (1888); 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 attempted and controlled bleeding briefly, new jada that also briefly controlled bleeding and then bleeding resumed.Bakri placed and bleeding continued, to hysterectomy/bleeding did not subside after 5-10 minutes of insertion [device ineffective] case narrative: this initial solicited report was received from a physician referring to a non-pregnant female patient of unknown age who was enrolled in a market research program entitled "jada drivers & barriers qualitative market research" conducted by trinity life sciences.The patient's medical history included pregnancy and had a delivery, her concurrent conditions and drug reactions/allergies were not reported.The patient's concomitant medications included oxytocin (pitocin) and methylergometrine maleate (methergine).This report concerns 1 patient and 2 devices.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (device number 1) by the physician for bleeding or postpartum uterine bleeding or hemorrhage (postpartum haemorrhage).It controlled bleeding briefly and vacuum-induced hemorrhage control system (jada system) (device number 1) was removed and replaced with a new vacuum-induced hemorrhage control system (jada system) (device number 2) by the physician for bleeding or postpartum uterine bleeding or hemorrhage (postpartum haemorrhage), that also briefly controlled bleeding (also reported as ¿bleeding did not subside after 5-10 minutes of insertion¿ and ¿vacuum-induced hemorrhage control system (jada system) (both devices 1 and 2) did not controlled the bleeding (continued uterine bleeding)¿) and then bleeding resumed (device ineffective).It was reported that bakri placed, and bleeding continued, to hysterectomy which resolved the bleeding.The patient sought medical attention and received treatment (discrepancy: also reported as prescription drug treatment for experience was not required).The patient did not die, no prolonged hospitalization, and no significant disability or incapacity was reported.On an unknown date, therapy with vacuum-induced hemorrhage control system (jada system) (device number 2) was discontinued.The both vacuum-induced hemorrhage control system (jada system) were not available for evaluation since both devices were disposed of after use.For both 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 as 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).
 
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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 Key16300917
MDR Text Key308824306
Report Number3002806821-2023-00011
Device Sequence Number1
Product Code OQY
Combination Product (y/n)N
PMA/PMN Number
510K K201199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Study,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
METHERGINE (METHYLERGOMETRINE MALEATE),; PITOCIN [OXYTOCIN] (OXYTOCIN),
Patient Outcome(s) Required Intervention;
Patient SexFemale
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