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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2022

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

The provider did not place it properly, placed it way up in the fundus and then pulled it out [wrong technique in device usage process].Case narrative: this spontaneous report originating from united states was received from clinical educator (ce) via clinical educator (also reported as nurse), referring to a female patient of unknown age.The patient's medical history, concurrent conditions, past drugs/allergies, and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date the patient used vacuum-induced hemorrhage control system (jada system) for single use (lot # was not reported) for an unknown indication.Reporter stated that clinical educator (ce) at the hospital reported to ce last night, (b)(6) 2014, that "the provider did not place it properly, placed it way up in the fundus and then pulled it out (wrong technique in device usage process).One was used and wasted because he did not use it the way he was trained." no further information available, no additional adverse event (ae) reported, no product quality compliant (pqc) reported.Medical attention was sought for the event.The availability of the vacuum-induced hemorrhage control system (jada system) for evaluation was unknown.Upon internal review the event wrong technique in device usage process was considered medically significant.Fda code: (health effects - health impact per annex f): (b)(4).

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

The provider did not place it properly, placed it way up in the fundus and then pulled it out [wrong technique in device usage process].Case narrative: this spontaneous report originating from united states was received from clinical educator (ce) via clinical educator (also reported as nurse), referring to a female patient of unknown age.The patient's medical history, concurrent conditions, past drugs/allergies, and concomitant medications were not reported.This report concerns 1 patient and 1 device.On an unknown date, the patient used vacuum-induced hemorrhage control system (jada system) for single use (lot # was not reported) for an unknown indication.Reporter stated that clinical educator (ce) at the hospital reported to ce last night, ((b)(6) 2022), that "the provider did not place it properly, placed it way up in the fundus and then pulled it out (wrong technique in device usage process).One was used and wasted because he did not use it the way he was trained." no further information available, no additional adverse event (ae) reported, no product quality compliant (pqc) reported.Medical attention was sought for the event.The availability of the vacuum-induced hemorrhage control system (jada system) for evaluation was unknown.Upon internal review the event wrong technique in device usage process was considered medically significant.Fda code: (health effects - health impact per annex f): 2199 no health consequences or impact (no apparent harm occurred in relation to the adverse event) follow up information was received from the physician on (b)(6) 2022.The physician had never used the device and her name was not reported correctly.She had received training but has not used the device and explained the reporter gave her information incorrectly.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.

• 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 Key: 16033826
• MDR Text Key: 305988658
• Report Number: 3002806821-2022-00030
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female