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

Lot Number UNKNOWN

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

Patient Problem Insufficient Information (4580)

Event Date 01/01/2024

Event Type  Injury  

Event Description

Nurses reported the patient was found to have an inverted uterus [uterine inversion] the patient removed the device herself while suction was still connected to the device [unintentional medical device removal] case narrative: this spontaneous report originating from united states was received from territory manager (tm) referring to a non-pregnant female patient of unknown age.The patient's concurrent conditions, concomitant medications and past drug reactions/allergies were not reported.The patient's medical history included pregnancy, delivery, para 1 and gravida 2.This report concerns 1 patient(s) and 1 device(s).On an unknown date approximately in 2024 (reported as couple of months ago), the patient was placed with vacuum-induced hemorrhage control system (jada system) via intravaginal route (after her first delivery) (lot# and expiration date were not reported) for postpartum hemorrhage.On an unknown date in 2024 (reported as couple of months ago), the system worked as normal, but the patient removed the device herself while suction was still connected to the device (unintentional medical device removal).The nurse reported that patient went to restroom for several hours later and felt something in her vagina.The nurse found that the patient had an inverted uterus (uterine inversion) which resulted in surgical intervention with hysterectomy.The patient was in hospital.On an unknown date in 2024, therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.It was unknown if the vacuum-induced hemorrhage control system (jada system) was available for evaluation.The outcome of event uterine inversion was unknown.Upon internal review, the event uterine inversion was determined to be serious due required intervention (devices).Medical device reporting criteria: serious injury 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.

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.

• 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: 19172465
• MDR Text Key: 340917164
• Report Number: 3002806821-2024-00036
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2024

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?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female