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 Implant Pain (4561)

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 physician via company representative referring to a female patient of unknown age.Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.This report concerns 1 device and 1 patient.On an unknown date, the patient was inserted with vacuum-induced hemorrhage control system (jada system), 1 unit via routed reported as intrauterine (strength, lot# and expiration date were not reported) for postpartum hemorrhage and had extreme pain with vacuum-induced hemorrhage control system (jada system) during use.No further information was provided.No additional adverse event (ae) reported, no product quality complaint (pqc) reported.The vacuum-induced hemorrhage control system (jada system) was removed.The outcome of the event pain was unknown.The reporter's causality assessment was not reported.Upon internal review, the event pain was determined to be medically significant.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4648 insufficient information (there is not yet enough information available to classify the health impact.).

• 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: 14950287
• MDR Text Key: 295477349
• Report Number: 3017425145-2022-00106
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• 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): Other
• Patient Sex: Female