MAUDE Adverse Event Report: ORGANON LLC JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The jada was used, and she continued to bleed so they were concerned [device ineffective].They removed the jada and appeared the inversion had not been completely resolved [contraindicated device used].No additional ae reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a nurse referring to a female patient of unknown age via clinical account specialist (cas).The patient's medical history, concomitant medications and past drug reactions/allergies were not reported.The patient's concurrent condition included uterine inversion.This report concerns 1 patient(s) and 1 device(s).On an unknown date in 2024 (also reported as couple of months ago), the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage.The vacuum-induced hemorrhage control system (jada system) was used, and the patient continued to bleed (device ineffective) so the nurse was concerned.They removed the vacuum-induced hemorrhage control system (jada system) and appeared the inversion had not been completely resolved (contraindicated device used) so they went ahead and resolved it again and used another vacuum-induced hemorrhage control system (jada system).The patient was still continued to bleed.The second vacuum-induced hemorrhage control system (jada system) was removed, and they noticed the uterine was still partially inverted.The nurse believed the patient got a hysterectomy.No further information was provided, no additional adverse event (ae) reported (no adverse event).Upon internal review, the event device ineffective was determined to be serious due to medically significant.This case was linked to same patient linked case included, patient underwent another vacuum-induced hemorrhage control system (jada system) and still continued to bleed (device ineffective).The second vacuum-induced hemorrhage control system (jada system) was removed, and they noticed the uterine was still partially inverted (contraindicated device used) (reported in oars #(b)(4)).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.Medical device reporting criteria: serious injury.
Additional 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 or Problem Description
The jada was used, and she continued to bleed so they were concerned [device ineffective] they removed the jada and appeared the inversion had not been completely resolved [contraindicated device used] no additional ae reported [no adverse event].Case narrative: this spontaneous report originating from united states was received from a nurse referring to a female patient of unknown age via clinical account specialist (cas).The patient's medical history, concomitant medications and past drug reactions/allergies were not reported.The patient's concurrent condition included uterine inversion.This report concerns 1 patient(s) and 1 device(s).On an unknown date in 2024 (also reported as couple of months ago), the patient was placed with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot #, serial # and expiration date were not reported) for postpartum hemorrhage.The vacuum-induced hemorrhage control system (jada system) was used, and the patient continued to bleed (device ineffective) so the nurse was concerned.They removed the vacuum-induced hemorrhage control system (jada system) and appeared the inversion had not been completely resolved (contraindicated device used) so they went ahead and resolved it again and used another vacuum-induced hemorrhage control system (jada system).The patient was still continued to bleed.The second vacuum-induced hemorrhage control system (jada system) was removed, and they noticed the uterine was still partially inverted.The nurse believed the patient got a hysterectomy.No further information was provided, no additional adverse event (ae) reported (no adverse event).Upon internal review, the event device ineffective was determined to be serious due to required intervention (devices).This case was linked to same patient linked case included, patient underwent another vacuum-induced hemorrhage control system (jada system) and still continued to bleed (device ineffective).The second vacuum-induced hemorrhage control system (jada system) was removed, and they noticed the uterine was still partially inverted (contraindicated device used) (reported in oars #(b)(4)).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.Medical device reporting criteria: serious injury.This is an amended report: updated seriousness of event "device ineffective" to required intervention (devices) from medically significant.

• Brand Name: JADA SYSTEM
• Common Device Name: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON LLC; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: tara brolly ; 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 21196047
• Report Number: 3002806821-2025-00003
• Device Sequence Number: 20701925
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: 00850017882003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female