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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 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.
 
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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 Key18171055
MDR Text Key328545308
Report Number3002806821-2023-00134
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 Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/15/2023
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
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/20/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/15/2023
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
Patient Outcome(s) Required Intervention;
Patient Age21 YR
Patient SexFemale
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