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

Model Number JADA-1001

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

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

Initial information originating from the united states has been received from an investigator referring to a 29-year-old, non-hispanic or latino white female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage (pph) with the jada system-a post-market registry".This report concerns 1 subject and 1 device.The subject's height was 157 centimeters (cm), weight was 60 kilograms (kg) and body mass index (bmi) was 24.34 (no units provided).On 28-aug-2021, hemoglobin at admission was 13.5 and at discharge it was 10.5 (no units provided).On 29-aug-2021, subject underwent emergency cesarean section for her 1st pregnancy with augmented type of labour and oxytocin was used for augmentation.Epidural anesthesia was used before pregnancy procedure.Baby weighed 3080 (units not provided), gestational age at delivery was 37.9 weeks.Abnormal postpartum causes were reported as uterine atony and placenta accrete.Treatments prior to vacuum-induced hemorrhage control system (jada system) at bleeding event were reported as carboprost, misoprostol and methylergometrine maleate (methergine).On 29-aug-2021 07:00, the vacuum-induced hemorrhage control system (jada system) was used for postpartum uterine bleeding or pph (lot and serial # were not provided).And vacuum-induced hemorrhage control system (jada system) was successful in controlling abnormal postpartum uterine bleeding or pph.Cumulative blood loss at time of insertion was 1000 (units not provided).Total amount of blood collected in canister during vacuum-induced hemorrhage control system (jada system) treatment was 250 (units not provided).Total cumulative blood loss for the event was 1250 (units not provided).Time from vacuum connection to control of abnormal bleeding with vacuum-induced hemorrhage control system (jada system) was 1-2 min.There was no recurrence of the bleeding and device was not removed and re-inserted for any reason.On 29-aug-2021 (reported as after delivery), subject had allergic reaction after consuming a nut (food allergy).Allergic reaction to nuts-resulted in shortness of breath, tachycardia, difficulty swallowing, rash and lip edema and was treated with intramuscular epinephrine, steroids and benadryl.Severity was reported as moderate.Subject's condition necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Vacuum-induced hemorrhage control system (jada system) was removed on 29-aug-2021 13:00.Subject was discharged on 31-aug-2021.Outcome of event was recovered.Event was not related to the vacuum-induced hemorrhage control system (jada system) device or procedure.Medical device reporting criteria: serious injury.Fda code: (health effects - health impact per annex f): 4641 unexpected medical intervention (patient required an unforeseen medical intervention, excluding surgery, which was not on the original treatment plan.).

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYATEM
• 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: 15019768
• MDR Text Key: 295953315
• Report Number: 3017425145-2022-00112
• 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: Study,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• 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
• Date Manufacturer Received: 11/16/2021
• 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: BENADRYL.; CARBOPROST; INTRAMUSCULAR EPINEPHRINE,; METHYLERGOMETRINE MALEATE (METHERGINE); MISOPROSTOL; OXYTOCIN; STEROIDS
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White