JADA SYSTEM
Report
- Report Number
- 3002806821-2025-00055
- Event Type
- Injury
- Date Received
- April 17, 2025
- Report Date
- June 9, 2025
- Manufacturer
- ORGANON LLC
- Product Code
- OQY
- UDI-DI
- 00840164521139
- PMA / PMN Number
- K212757
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
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. 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.
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. 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.
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 AN AMENDMENT REPORT: CHECKED THE CHECKBOX OF SIGNIFICANT FOR DEVICE FOR 5TH REVISION WITH AWARE DATE: 07-MAY-2025.
REVIEW OF TROUBLESHOOTING STEPS WHEN JADA ISN'T WORKING AS EXPECTED. [DEVICE INEFFECTIVE] NO PQC REPORTED. NO ADDITIONAL AE REPORTED. [NO ADVERSE EVENT] CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A CONSUMER REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA SOCIAL MEDIA. THE PATIENT'S MEDICAL HISTORY, CURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 VIA INTRAVAGINAL ROUTE (DEFAULTED) (LOT NUMBER 110906 IS AN INVALID LOT NUMBER FOR VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). LOT NUMBER 110906 DOES NOT MATCH ANY OTHER COMPANY PRODUCT AS CONFIRMED BY THE LOT VERIFICATION TEAM. EXPIRATION DATE WAS REPORTED AS DECEMBER 2024. SERIAL# WAS NOT REPORTED) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WASN'T WORKING AS EXPECTED (DEVICE INEFFECTIVE). NO ADDITIONAL ADVERSE EVENT (AE) REPORTED (NO ADVERSE EVENT), NO PRODUCT QUALITY COMPLAINT (PQC) REPORTED. UPON INTERNAL REVIEW, THE EVENT DEVICE INEFFECTIVE WAS DETERMINED TO BE MEDICALLY SIGNIFICANT. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO MEDICAL INTERVENTION. THIS IS AN INTERNAL LOT NUMBER VALIDATION PERFORMED FOR LOT NUMBER 110906.
REVIEW OF TROUBLESHOOTING STEPS WHEN JADA ISN'T WORKING AS EXPECTED. [DEVICE INEFFECTIVE] NO PQC REPORTED. NO ADDITIONAL AE REPORTED. [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM AN ARTIFICIAL INTELLIGENCE (AI) DETECTOR REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA SOCIAL MEDIA. THE PATIENT'S MEDICAL HISTORY, CURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 VIA INTRAVAGINAL ROUTE (DEFAULTED) (LOT# WAS REPORTED AS 110906 AND EXPIRATION DATE WAS REPORTED AS DECEMBER 2024. SERIAL# WAS NOT REPORTED) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS NOT WORKED AS EXPECTED (DEVICE INEFFECTIVE). NO ADDITIONAL ADVERSE EVENT (AE) REPORTED (NO ADVERSE EVENT), NO PRODUCT QUALITY COMPLAINT (PQC) REPORTED. UPON INTERNAL REVIEW, THE EVENT DEVICE INEFFECTIVE WAS DETERMINED TO BE MEDICALLY SIGNIFICANT. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO MEDICAL INTERVENTION.
REVIEW OF TROUBLESHOOTING STEPS WHEN JADA ISN'T WORKING AS EXPECTED. [DEVICE INEFFECTIVE] NO PQC REPORTED. NO ADDITIONAL AE REPORTED. [NO ADVERSE EVENT] . CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A CONSUMER REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA SOCIAL MEDIA. THE PATIENT'S MEDICAL HISTORY, CURRENT CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 VIA INTRAVAGINAL ROUTE (DEFAULTED) (LOT NUMBER 110906 IS AN INVALID LOT NUMBER FOR VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). LOT NUMBER 110906 DOES NOT MATCH ANY OTHER COMPANY PRODUCT AS CONFIRMED BY THE LOT VERIFICATION TEAM. EXPIRATION DATE WAS REPORTED AS DECEMBER 2024. SERIAL# WAS NOT REPORTED) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WASN'T WORKING AS EXPECTED (DEVICE INEFFECTIVE). NO ADDITIONAL ADVERSE EVENT (AE) REPORTED (NO ADVERSE EVENT), NO PRODUCT QUALITY COMPLAINT (PQC) REPORTED. UPON INTERNAL REVIEW, THE EVENT DEVICE INEFFECTIVE WAS DETERMINED TO BE MEDICALLY SIGNIFICANT. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO MEDICAL INTERVENTION. THIS IS AN INTERNAL LOT NUMBER VALIDATION PERFORMED FOR LOT NUMBER 110906. FOLLOW-UP INFORMATION HAS BEEN RECEIVED FROM QUALITY INVESTIGATION TEAM ON 07-MAY-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 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. G07003 INSUFFICIENT COMPONENT INFORMATION. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO MEDICAL 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. THIS IS AN AMENDMENT REPORT: CHECKED THE CHECKBOX OF SIGNIFICANT FOR DEVICE FOR 5TH REVISION WITH AWARE DATE: 07-MAY-2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25238 | JADA SYSTEM | INTRAUTERINE VACUUM CONTRACTION SYSTEM | OQY | ORGANON LLC | 2002 | 110906 | 00840164521139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |