JADA SYSTEM
Report
- Report Number
- 3002806821-2025-00079
- Event Type
- Injury
- Date Received
- October 28, 2025
- Date of Event
- October 1, 2025
- Report Date
- January 1, 2026
- Manufacturer
- ORGANON LLC
- Product Code
- OQY
- UDI-DI
- 00840164521139
- PMA / PMN Number
- K212757
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 117
Narratives
THE MODEL NUMBER INFORMATION WAS NOT REPORTED OR NOT KNOWN BY THE REPORTER. HENCE, WE CANNOT DEFINITIVELY DETERMINE THE MODEL WITH THE INFORMATION PROVIDED. MODEL 2 WAS SELECTED AS THERE IS A MUCH HIGHER PROBABILITY THAT THIS MODEL WAS USED AS ORGANON IS CURRENTLY ONLY MANUFACTURING/MARKETING THIS MODEL. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.
THE MODEL NUMBER INFORMATION WAS NOT REPORTED OR NOT KNOWN BY THE REPORTER. HENCE, WE CANNOT DEFINITIVELY DETERMINE THE MODEL WITH THE INFORMATION PROVIDED. MODEL 2 WAS SELECTED AS THERE IS A MUCH HIGHER PROBABILITY THAT THIS MODEL WAS USED AS ORGANON IS CURRENTLY ONLY MANUFACTURING/MARKETING THIS MODEL. NO COMPLAINT SAMPLE OR DEVICE LOT NUMBER ARE AVAILABLE FOR EVALUATION, THEREFORE AN UNKNOWN INVESTIGATION WAS PERFORMED. THE DEVICE IS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS ARE CONDUCTED BY TRAINED PERSONNEL. NO OUTCOME FROM THE INVESTIGATION COULD BE DETERMINED SINCE NO COMPLAINT SAMPLE OR LOT IDENTIFICATION HAS BEEN PROVIDED. IF THE COMPLAINT SAMPLE OR LOT NUMBER BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED AND ADDITIONAL INVESTIGATION MAY BE PERFORMED. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.
THE MODEL NUMBER INFORMATION WAS NOT REPORTED OR NOT KNOWN BY THE REPORTER. HENCE, WE CANNOT DEFINITIVELY DETERMINE THE MODEL WITH THE INFORMATION PROVIDED. MODEL 2 WAS SELECTED AS THERE IS A MUCH HIGHER PROBABILITY THAT THIS MODEL WAS USED AS ORGANON IS CURRENTLY ONLY MANUFACTURING/MARKETING THIS MODEL. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.
UTERINE VOLUME BEGAN INCREASING RAPIDLY/ABDOMEN BECAME DISTENDED [ABDOMINAL DISTENSION] JADA BECAME BLOCKED BY LARGE CLOTS MAKE IT LESS EFFECTIVE [DEVICE OCCLUSION] JADA BECAME BLOCKED BY LARGE CLOTS MAKE IT LESS EFFECTIVE [DEVICE INEFFECTIVE] UNAPPROVED RECOMMENDATION: A POSTPARTUM PATIENT 17 DAYS [DEVICE USE ISSUE] INSERTION WAS MORE DIFFICULT [DEVICE DIFFICULT TO USE] LARGE CLOTS THAT WERE LIKELY ALREADY PRESENT IN THE UTERUS BEFORE INSERTION [DEVICE USE ERROR]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM CANADA WAS RECEIVED FROM A NURSE REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE 17 DAYS POSTPARTUM PATIENT UNDERWENT A DILATION AND CURETTAGE DUE TO RETAINED PLACENTAL FRAGMENTS IN HER UTERUS. PRIOR TO THE PROCEDURE, THE PATIENT WAS IN HEMORRHAGIC SHOCK. HER HEMOGLOBIN LEVEL HAD DROPPED TO AROUND 50. DURING THE CURETTAGE, THE BLEEDING DID NOT IMPROVE SIGNIFICANTLY. THE PATIENT'S DRUG REACTIONS OR ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT (S) AND 1 DEVICE (S). APPROXIMATELY IN (B)(6) 2025 (REPORTED AS THIS WEEK), THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2002 VIA VAGINAL ROUTE (DEFAULTED) (LOT # AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HEMORRHAGE 17 DAYS POSTPARTUM (DEVICE USE ISSUE) AND THE INSERTION WAS MORE DIFFICULT (DEVICE DIFFICULT TO USE) THAN IT WOULD BE FOR A PATIENT IN LABOR. THE PHYSICIAN PERFORMED CERVICAL DILATION USING A COOK CANNULA AND THE CURETTAGE TRAY CANNULAS. WITH SOME EFFORT, THE PHYSICIAN MANAGED TO INSERT THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). ONCE SUCTION WAS APPLIED, IT DRAINED APPROXIMATELY 100-125 ML, AND THEN NOTHING MORE. THE ISSUE WITH THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS THAT THE UTERINE VOLUME BEGAN INCREASING RAPIDLY. THE ABDOMEN BECAME DISTENDED (ABDOMINAL DISTENSION) AND VERY FIRM, WHILE THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS NO LONGER ASPIRATING ANYTHING. ULTIMATELY, THE PATIENT REQUIRED A HYSTERECTOMY. IT APPEARED THAT THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) BECAME BLOCKED BY LARGE CLOTS (DEVICE OCCLUSION) THAT WERE LIKELY ALREADY PRESENT IN THE UTERUS BEFORE INSERTION. THESE CLOTS OBSTRUCTED THE SUCTION, MAKING THE DEVICE LESS EFFECTIVE (DEVICE INEFFECTIVE). THE OUTCOME OF ABDOMINAL DISTENSION WAS UNKNOWN. THE REPORTER'S CAUSALITY ASSESSMENT OF EVENT ABDOMINAL DISTENSION WITH SUSPECT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS NOT REPORTED. UPON INTERNAL REVIEW, THE EVENTS DEVICE INEFFECTIVE, DEVICE OCCLUSION AND ABDOMINAL DISTENSION WAS CONSIDERED TO BE MEDICALLY SIGNIFICANT.
FOLLOW-UP INFORMATION HAS BEEN RECEIVED FROM QUALITY INVESTIGATION TEAM ON 28-DEC-2025. THIS IS A FINAL REPORT. MANUFACTURING STATEMENT: NO COMPLAINT SAMPLE OR DEVICE LOT NUMBER ARE AVAILABLE FOR EVALUATION; THEREFORE, AN UNKNOWN INVESTIGATION WAS PERFORMED. THE DEVICE WAS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS ARE CONDUCTED BY TRAINED PERSONNEL. NO OUTCOME FROM THE INVESTIGATION COULD BE DETERMINED SINCE NO COMPLAINT SAMPLE OR LOT IDENTIFICATION HAS BEEN PROVIDED. IF THE COMPLAINT SAMPLE OR LOT NUMBER BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, AND ADDITIONAL INVESTIGATION MAY BE PERFORMED.
THIS IS AN AMENDMENT REPORT. UPDATED DETERMINED CAUSALITY OF THE EVENT ABDOMINAL DISTENSION FROM UNKNOWN TO NOT ASSESSED AND TO CHECK PRODUCT PROBLEM CHECK BOX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19479 | JADA SYSTEM | INTRAUTERINE VACUUM CONTRACTION SYSTEM | OQY | ORGANON LLC | JADA-2002 | 00840164521139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |