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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 No Clinical Signs, Symptoms or Conditions (4582)
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
No blood coming through the suction [device issue].Case narrative: this spontaneous report originating from the united states was received from a physician via clinical educator, referring to a patient of unknown age and gender.The patient's medicated history, current conditions, past drugs/ allergies and concomitant medications were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route for an unknown indication by the physician.Reportedly, provider reported that he used the vacuum-induced hemorrhage control system (jada system) on a patient and once it was inserted there was no blood coming through the suction (device issue).Provider reported that he removed that vacuum-induced hemorrhage control system (jada system) and inserted a new one which worked perfectly, and the patient did well.Provider reported he thought something was wrong with the first device.Upon internal review, the event device issue was considered as medically significant.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.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
No blood coming through the suction [device issue] case narrative: this spontaneous report originating from the united states was received from a physician via clinical educator, referring to a female patient of unknown age.The patient's medicated history, current conditions, past drugs/ allergies and concomitant medications were not reported.This report concerned 1 patient and 1 device.On an unknown date, the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route for an unknown indication by the physician.Reportedly, provider reported that he used the vacuum-induced hemorrhage control system (jada system) on a patient and once it was inserted there was no blood coming through the suction (device issue).Provider reported that he removed that vacuum-induced hemorrhage control system (jada system) and inserted a new one which worked perfectly, and the patient did well.Provider reported he thought something was wrong with the first device.The patient sought medical attention.Upon internal review, the event device issue was considered as medically significant.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.For vacuum-induced hemorrhage control system (jada system), lot number and serial number were not provided.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): 4642 additional device required (use of an additional or alternative device require to achieve optimal outcome).This is an amended report to update patient gender as female as the route of administration was provided as vaginal.Checked "product problem" checkbox in medwatch info tab.
 
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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 Key18198429
MDR Text Key328892105
Report Number3002806821-2023-00136
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 Physician
Type of Report Initial,Followup
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
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) Other;
Patient SexFemale
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