MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Model Number JADA-1001

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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

This spontaneous report was received from a other health professional (nurse) referring to a non-pregnant female patient of unknown age, via rocky mountain poison & drug safety (rmpds) and merck.The patient's medical history, concomitant medications and past drug reactions/allergies were not reported.The patient's current condition included hospitalization.This report concerned 1 patient and 1 device.On (b)(6) 2022, the patient inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route (strength, lot # and expiration date were not reported) for 3200 blood loss or for control of postpartum haemorrhage (pph) and had the suction in and would go for hysterectomy (device ineffective).The patient's hospitalization was prolonged due to the event.The reporter reported that they wanted to make sure that the suction could be for 1-24 hours and asked to confirm whether this was correct.No additional details were known.No additional adverse event (ae) identified; no product quality compliant (pqc) identified.Upon internal review, the event device ineffective was considered as serious due to hospitalization and due to required intervention (devices).Medical device reporting criteria: serious injury.(b)(4).

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ALYDIA HEALTH; 3495 edison way; menlo park; CA 94025
• Manufacturer (Section G): ALYDIA HEALTH; 3495 edison way; menlo park; CA 94025
• Manufacturer Contact: 3495 edison way; menlo park
• MDR Report Key: 15008415
• MDR Text Key: 295861989
• Report Number: 3017425145-2022-00110
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 00850017882003
• UDI-Public: (01)00850017882003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 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
• Report Date: 07/13/2022

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 Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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