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 physician referring to a female patient of unknown age.The patient's medical history included first pregnancy (gravida 1), postpartum haemorrhage and vaginal delivery.The patient's concurrent conditions were not provided and concomitant medications included unspecified pain medication.The patient was not pregnant.This report concerns 1 device and 1 patient.On an unknown date in 2022, the patient was inserted with vacuum-induced hemorrhage control system (jada system) (strength, lot# and expiration date were not reported) for postpartum hemorrhage by physician.Vacuum-induced hemorrhage control system (jada system) was then removed after 22 hours of use.Vacuum-induced hemorrhage control system (jada system) was successful and stopped the hemorrhaging.Patient was discharged home 2 days after delivery.On postpartum day 6 patient went to the emergency room because she could not void urine.Emergency room physician had nurse place foley catheter to patient's bladder and 2500 milliliters (ml) of urine was drained.On an unknown date in (b)(6) 2022, the physician examined the patient and found her to have an inverted uterus (uterine inversion) on exam.Patient was admitted overnight in the hospital.It was reported that bleeding was not continued or restarted during the vacuum-induced hemorrhage control system (jada system) verification step.There was no another bleeding episode after initial bleeding was controlled by vacuum-induced hemorrhage control system (jada system).Not more than one device was used.Device was not removed and reinserted for any reason.On an unknown date in 2022, the patient was recovered from the event.Causality assessment was not provided.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: 15210165
• MDR Text Key: 297702785
• Report Number: 3017425145-2022-00131
• 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: 08/11/2022

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 Operator: Health Professional
• Device Model Number: JADA-1001
• Device Catalogue Number: JADA-1001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PAIN MEDICATION
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female