JADA SYSTEM
Report
- Report Number
- 3002806821-2023-00036
- Event Type
- Injury
- Date Received
- April 11, 2023
- Report Date
- May 25, 2023
- Manufacturer
- ORGANON & CO.
- Product Code
- OQY
- PMA / PMN Number
- 510K K201199
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
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.
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.
BLOOD PRESSURE DROPPED 71/42 [BLOOD PRESSURE DECREASED]. SEROSANGUINOUS FLUID WAS COMING OUT AROUND JADA/LEAKING [DEVICE LEAKAGE]. CLOTS WERE EXPRESSED [DEVICE OCCLUSION]. EARS MUFFLED [HYPOACUSIS]. FELT LIKE SHE WAS GOING TO PASS OUT [DIZZINESS]. JUST SOME DISCOMFORT [DISCOMFORT]. ONLY 60 ML OF FLUID REMAINED, APPEARED TO BE DEFECTIVE [DEVICE DEFECTIVE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT ORIGINATING FROM THE UNITED STATES WAS RECEIVED FROM A "OR" INVENTORY CONTROL LEAD VIA CLINICAL ACCOUNT SPECIALIST (CAS) REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT WAS INSERTED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (LOT#: 1070334 AND EXPIRY DATE WAS NOT REPORTED; ITEM NUMBER WAS REPORTED AS JADA-2001) BY HEALTHCARE PROFESSIONAL FOR AN UNKNOWN INDICATION. VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS PLACED WITH 100 ML OF FLUID PLACED. THE PATIENT CALLED OUT AND STATED SHE DID NOT FEEL RIGHT, EARS MUFFLED (HYPOACUSIS) AND FELT LIKE SHE WAS GOING TO PASS OUT (DIZZINESS), BLOOD PRESSURE DROPPED 71/42 (UNIT NOT REPORTED) (BLOOD PRESSURE DECREASED). UPON ASSESSMENT IT WAS NOTED THAT SEROSANGUINOUS FLUID WAS COMING OUT AROUND VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (DEVICE LEAKAGE). THE PHYSICIAN WAS AT BEDSIDE TO ASSESS, AND VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS TAKEN OUT, WHEN DEFLATED IT WAS NOTED THAT ONLY 60 ML OF FLUID REMAINED, APPEARED TO BE DEFECTIVE (DEVICE DEFECTIVE) AND LEAKING. IT WAS REPORTED THAT PATIENT WAS DOING WELL JUST SOME DISCOMFORT. THE CLOTS WERE EXPRESSED (DEVICE OCCLUSION) AND NEW VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS PLACED. THE CAS ASKED IF THEY COULD GET A REPLACEMENT AT NO-COST SINCE THE UNIT WAS DEFECTIVE. THE DEFECTIVE UNIT WAS NOT AVAILABLE FOR RETRIEVAL. THE OUTCOME OF EVENTS HYPOACUSIS, BLOOD PRESSURE DECREASED, AND DIZZINESS WAS CONSIDERED AS RECOVERING, IT WAS UNKNOWN FOR DISCOMFORT. THE REPORTER'S CAUSALITY ASSESSMENT WAS NOT PROVIDED. UPON INTERNAL REVIEW, THE EVENTS OF DEVICE LEAKAGE AND DEVICE OCCLUSION WERE CONSIDERED TO BE SERIOUS DUE TO REQUIRED INTERVENTION. UPON INTERNAL REVIEW, THE EVENT OF BLOOD PRESSURE DECREASED WAS CONSIDERED TO BE MEDICALLY SIGNIFICANT. THIS IS THE FINAL REPORT. COMPLAINT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. REVIEW ELEMENTS OF THE EVENT INCLUDED LOT RECORD PACKAGE (DHR), NON-CONFORMANCES, MANUFACTURING CONTROLS, CAPA LOG AND COMPLAINT TRENDS. THE DEVICE IS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS ARE CONDUCTED BY TRAINED PERSONNEL. IN PROCESS AND FINISHED PRODUCT TESTING IS PERFORMED AND APPROVED PRIOR TO RELEASE. BASED ON THE INFORMATION RECEIVED, THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED AND ADDITIONAL INVESTIGATION MAY BE PERFORMED. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. FDA CODE: (HEALTH EFFECTS - HEALTH IMPACT PER ANNEX F): 4641 UNEXPECTED MEDICAL INTERVENTION (PATIENT REQUIRED AN UNFORESEEN MEDICAL INTERVENTION, EXCLUDING SURGERY, WHICH WAS NOT ON THE ORIGINAL TREATMENT PLAN).
BLOOD PRESSURE DROPPED 71/42 [BLOOD PRESSURE DECREASED], SEROSANGUINOUS FLUID WAS COMING OUT AROUND JADA/LEAKING [DEVICE LEAKAGE], CLOTS WERE EXPRESSED [DEVICE OCCLUSION], EARS MUFFLED [HYPOACUSIS], FELT LIKE SHE WAS GOING TO PASS OUT [DIZZINESS], JUST SOME DISCOMFORT [DISCOMFORT], ONLY 60 ML OF FLUID REMAINED, APPEARED TO BE DEFECTIVE [DEVICE DEFECTIVE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT ORIGINATING FROM THE UNITED STATES WAS RECEIVED FROM A "OR" INVENTORY CONTROL LEAD VIA CLINICAL ACCOUNT SPECIALIST (CAS) REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT WAS INSERTED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (LOT# 1070334 AND EXPIRY DATE WAS NOT REPORTED; ITEM NUMBER WAS REPORTED AS JADA-2001) BY HEALTHCARE PROFESSIONAL FOR AN UNKNOWN INDICATION. VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS PLACED WITH 100 ML OF FLUID PLACED. THE PATIENT CALLED OUT AND STATED SHE DID NOT FEEL RIGHT, EARS MUFFLED (HYPOACUSIS) AND FELT LIKE SHE WAS GOING TO PASS OUT (DIZZINESS), BLOOD PRESSURE DROPPED 71/42 (UNIT NOT REPORTED) (BLOOD PRESSURE DECREASED). UPON ASSESSMENT IT WAS NOTED THAT SEROSANGUINOUS FLUID WAS COMING OUT AROUND VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (DEVICE LEAKAGE). THE PHYSICIAN WAS AT BEDSIDE TO ASSESS, AND VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS TAKEN OUT, WHEN DEFLATED IT WAS NOTED THAT ONLY 60 ML OF FLUID REMAINED, APPEARED TO BE DEFECTIVE (DEVICE DEFECTIVE) AND LEAKING. IT WAS REPORTED THAT PATIENT WAS DOING WELL JUST SOME DISCOMFORT. THE CLOTS WERE EXPRESSED (DEVICE OCCLUSION) AND NEW VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS PLACED. THE CAS ASKED IF THEY COULD GET A REPLACEMENT AT NO-COST SINCE THE UNIT WAS DEFECTIVE. THE DEFECTIVE UNIT WAS NOT AVAILABLE FOR RETRIEVAL. THE OUTCOME OF EVENTS HYPOACUSIS, BLOOD PRESSURE DECREASED, AND DIZZINESS WAS CONSIDERED AS RECOVERING, IT WAS UNKNOWN FOR DISCOMFORT. THE REPORTER'S CAUSALITY ASSESSMENT WAS NOT PROVIDED. UPON INTERNAL REVIEW, THE EVENTS OF DEVICE LEAKAGE AND DEVICE OCCLUSION WERE CONSIDERED TO BE SERIOUS DUE TO REQUIRED INTERVENTION. UPON INTERNAL REVIEW, THE EVENT OF BLOOD PRESSURE DECREASED WAS CONSIDERED TO BE MEDICALLY SIGNIFICANT. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. FDA CODE: (HEALTH EFFECTS - HEALTH IMPACT PER ANNEX F): 4641 UNEXPECTED MEDICAL INTERVENTION (PATIENT REQUIRED AN UNFORESEEN MEDICAL INTERVENTION, EXCLUDING SURGERY, WHICH WAS NOT ON THE ORIGINAL TREATMENT PLAN.)
BLOOD PRESSURE DROPPED 71/42 [BLOOD PRESSURE DECREASED] . SEROSANGUINOUS FLUID WAS COMING OUT AROUND JADA/LEAKING [DEVICE LEAKAGE] . CLOTS WERE EXPRESSED [DEVICE OCCLUSION] . EARS MUFFLED [HYPOACUSIS] . FELT LIKE SHE WAS GOING TO PASS OUT [DIZZINESS] . JUST SOME DISCOMFORT [DISCOMFORT] . ONLY 60 ML OF FLUID REMAINED, APPEARED TO BE DEFECTIVE [DEVICE DEFECTIVE] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT ORIGINATING FROM THE UNITED STATES WAS RECEIVED FROM A "OR" INVENTORY CONTROL LEAD VIA CLINICAL ACCOUNT SPECIALIST (CAS) REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON AN UNKNOWN DATE, THE PATIENT WAS INSERTED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (LOT# 1070334 AND EXPIRY DATE WAS NOT REPORTED; ITEM NUMBER WAS REPORTED AS JADA-2001) BY HEALTHCARE PROFESSIONAL FOR AN UNKNOWN INDICATION. VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS PLACED WITH 100 ML OF FLUID PLACED. THE PATIENT CALLED OUT AND STATED SHE DID NOT FEEL RIGHT, EARS MUFFLED (HYPOACUSIS) AND FELT LIKE SHE WAS GOING TO PASS OUT (DIZZINESS), BLOOD PRESSURE DROPPED 71/42 (UNIT NOT REPORTED) (BLOOD PRESSURE DECREASED). UPON ASSESSMENT IT WAS NOTED THAT SEROSANGUINOUS FLUID WAS COMING OUT AROUND VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (DEVICE LEAKAGE). THE PHYSICIAN WAS AT BEDSIDE TO ASSESS, AND VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS TAKEN OUT, WHEN DEFLATED IT WAS NOTED THAT ONLY 60 ML OF FLUID REMAINED, APPEARED TO BE DEFECTIVE (DEVICE DEFECTIVE) AND LEAKING. IT WAS REPORTED THAT PATIENT WAS DOING WELL JUST SOME DISCOMFORT. THE CLOTS WERE EXPRESSED (DEVICE OCCLUSION) AND NEW VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS PLACED. THE CAS ASKED IF THEY COULD GET A REPLACEMENT AT NO-COST SINCE THE UNIT WAS DEFECTIVE. THE DEFECTIVE UNIT WAS NOT AVAILABLE FOR RETRIEVAL. THE OUTCOME OF EVENTS HYPOACUSIS, BLOOD PRESSURE DECREASED, AND DIZZINESS WAS CONSIDERED AS RECOVERING, IT WAS UNKNOWN FOR DISCOMFORT. THE REPORTER'S CAUSALITY ASSESSMENT WAS NOT PROVIDED. UPON INTERNAL REVIEW, THE EVENTS OF DEVICE LEAKAGE AND DEVICE OCCLUSION WERE CONSIDERED TO BE SERIOUS DUE TO REQUIRED INTERVENTION. UPON INTERNAL REVIEW, THE EVENT OF BLOOD PRESSURE DECREASED WAS CONSIDERED TO BE MEDICALLY SIGNIFICANT. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. FDA CODE: (HEALTH EFFECTS - HEALTH IMPACT PER ANNEX F): 4641 UNEXPECTED MEDICAL INTERVENTION (PATIENT REQUIRED AN UNFORESEEN MEDICAL INTERVENTION, EXCLUDING SURGERY, WHICH WAS NOT ON THE ORIGINAL TREATMENT PLAN.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1623273 | JADA SYSTEM | INTRAUTERINE VACUUM CONTRACTION SYSTEM | OQY | ORGANON & CO. | 1070334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention| O |