• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 02/01/2023
Event Type  Injury  
Event Description
Three unknown providers attempted to insert jada (unknown if one or three different jada devices used) but they "couldn't get it to work/the jada device stop control the bleeding [device ineffective] device would not work due to the retroverted uterus and the patients anatomy [contraindicated device used] case narrative: this spontaneous report originating from united states was received from nurse via field representative, referring to a female patient of unknown age.On an unknown date in 2022, the patient became pregnant.On an unknown date in (b)(6) 2023, the patient gave birth to twins via cesarean section by 4-centimeter (cm) dilatation.During cesarean section, it was observed that patient had retroverted uterus and the retroverted uterus was not surgically corrected as the patient was not considered to have any risk factors.After the cesarean section, the patient started bleeding.The patient's concomitant medications and drug reactions / allergies were not reported.This report concerned 1 patient and 1 device.On an unknown date in (b)(6) 2023, the patient had vacuum-induced hemorrhage control system (jada system) insertion (lot# and expiration date were not reported) for bleeding (postpartum haemorrhage) by three unknown providers (health care professional).It was unknown if one or three different vacuum-induced hemorrhage control system (jada system) devices used but they could not get it to work, and the vacuum-induced hemorrhage control system (jada system) device did not stop control the bleeding (device ineffective).The providers then followed escalating treatment which was required after vacuum-induced hemorrhage control system (jada system) use to control abnormal postpartum uterine bleeding or hemorrhage and inserted bakri uterine balloon tamponade by surgical intervention which also failed.It was reported that the device would not work due to the retroverted uterus and the patient's anatomy (contraindicated device used).The reporter did not know if any other interventions were attempted or the outcome for the patient.No additional information provided.No additional adverse event (ae)/ product quality complaint (pqc) reported.For vacuum-induced hemorrhage control system (jada system), the lot number is not available, and the serial number is not available.Therapy with vacuum-induced hemorrhage control system (jada system) was withdrawn on an unknown date in (b)(6) 2023.The outcome of device ineffective and contraindicated device used was unknown.The reporter's causality assessment was not provided.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).
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key16528249
MDR Text Key311141375
Report Number3002806821-2023-00020
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
Report Date 03/10/2023
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/13/2023
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 SexFemale
-
-