Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)
Event Date 06/01/2023
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 work [device ineffective] no additional ae identified [no adverse event] case narrative: this spontaneous report originating from united states was received from a physician via clinical sales educator referring to a female patient of unknown age.The patient's medical history included on an unknown date in (b)(6) 2023 (also reported as approximately 9 months ago), she had a patient deliver (delivery) and the current condition included patient developed uterine atony.The patient's past drug reactions or allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date in (b)(6) 2023 (reported as approximately 9 months ago), the patient was placed with vacuum-induced hemorrhage control system (jada system) (lot and expiration date were not reported) via vaginal route for uterine atony.On an unknown date in (b)(6) 2023 (also reported as approximately 9 months ago), the physician inserted the vacuum-induced hemorrhage control system (jada system) and cervical seal was inflated, suction applied.It was reported that over the course of 10 minutes the suction canister filled with over 1000 milliliters of blood.The uterus did not become firm.The physician took the patient to the operating room, removed the vacuum-induced hemorrhage control system (jada system), and performed a hysterectomy.The physician did not report anything being wrong with the vacuum-induced hemorrhage control system (jada system), just that it did not work (device ineffective).No additional adverse event (no adverse event) and product quality complaint identified.The patient sought medical attention.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The outcome of device ineffective and no adverse event was unknown.Medical device reporting criteria: serious injury 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.
 
Event Description
Did not work [device ineffective].No additional ae identified [no adverse event].Case narrative: this spontaneous report originating from united states was received from a physician via clinical sales educator referring to a female patient of unknown age.The patient's medical history included on an unknown date in june 2023 (also reported as approximately 9 months ago), she had a patient deliver (delivery) and the current condition included patient developed uterine atony.The patient's past drug reactions or allergies and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date on (b)(6) 2023, (reported as approximately 9 months ago), the patient was placed with vacuum-induced hemorrhage control system (jada system) (lot and expiration date were not reported) via vaginal route for uterine atony.The clinical sales educator (cse) was reporting behalf of a provider and another cse (name not given) was attending a conference on (b)(6) 2024 and this ae was reported to that cse by the provider.On an unknown date on (b)(6) 2023 (also reported as approximately 9 months ago), the physician inserted the vacuum-induced hemorrhage control system (jada system) and cervical seal was inflated, suction applied.It was reported that over the course of 10 minutes the suction canister filled with over 1000 milliliters of blood.The uterus did not become firm.The physician took the patient to the operating room, removed the vacuum-induced hemorrhage control system (jada system), and performed a hysterectomy.The physician did not report anything being wrong with the vacuum-induced hemorrhage control system (jada system), just that it did not work (device ineffective).No additional adverse event (no adverse event) and product quality complaint identified.The patient sought medical attention.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The outcome of device ineffective was unknown.Upon internal review, the event device ineffective was determined to be medically significant.The reporter considered the event device ineffective as serious due to hospitalization.Medical device reporting criteria: serious injury.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.This is an amendment report to check correspondence check box for primary reporter, to update hospitalization date, to update seriousness for events in narrative and to update narrative.
 
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 Key18845491
MDR Text Key336981340
Report Number3002806821-2024-00016
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 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
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
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) Other; Hospitalization;
Patient SexFemale
-
-