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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM
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ALYDIA HEALTH JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM Back to Search Results
Model Number JADA-1001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fever (1858)
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 38-year-old, non-hispanic or latino asian female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage with the jada system-a post-market registry".This report concerns 1 subject and 1 device.The subject's current conditions included gestational hypertension and uterine atony, history included gravida 2 and para 2, live births 1, cesarean 1, uterine artery ligation and a therapeutic abortion.The subject's height was 156.2 centimeter (cm), weight was 68.7 kilogram (kg), body mass index (bmi) 28.16 (no units provided).On (b)(6) 2021, hemoglobin at admission was 14.7 (no units provided) and on (b)(6) 2021, at discharge was 10.5 (no units provided).The gestational age at delivery was 37.9 weeks.Type of labor was scheduled cesarean.Oxytocin was used at delivery at placenta for 4 hours post-delivery.On (b)(6) 2021 at 21:58, the subject had placental delivery of a singleton of weight 2470 grams, with no vaginal or cervical lacerations.Spinal anaesthesia was used.Uterine atony was present and a blood loss equal to 1300 (unit not reported) was noted.The interventions given prior to use of vacuum-induced hemorrhage control system (jada system) were 2 doses of carboprost, misoprostol, one dose of methylergometrine maleate (methergine), one dose of tranexamic acid (txa) and uterine artery ligation.On (b)(6) 2021 at 22:20, the vacuum-induced hemorrhage control system (jada system) was used for postpartum hemorrhage (lot and serial # were not provided).The total duration of vacuum-induced hemorrhage control system (jada system) indwelling time was 3.67 (units not reported).The total duration of vacuum-induced hemorrhage control system (jada system) admission to subject discharge from hospital was 72.68 (units not reported).The total duration of vacuum-induced hemorrhage control system (jada system) removal to subject discharge from hospital was 60.25 (units not reported).Total cumulative blood loss for the event 1500 (unit not reported).1 dose of carboprost was given during or after vacuum-induced hemorrhage control system (jada system).On (b)(6) 2022, the subject suffered with postpartum fever of unknown etiology (puerperal pyrexia) (mild) and treated with postpartum antibiotics like gentamicin and clindamycin which helped to resolve the fever on the same day.These antibiotics were also used as pre-operative drugs for cesarean delivery.After vacuum-induced hemorrhage control system (jada system) use, the subject was transfused with cell salvage 250 units for postpartum hemorrhage (pph).Therapy was withdrawn on (b)(6) 2021 at 02:00.The subject was discharged from the hospital on (b)(6) 2021 at 14:15.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review, the event puerperal pyrexia was determined to be medically significant.Medical device reporting criteria: serious injury.(b)(4).
 
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 38-year-old, non-hispanic or latino asian female subject enrolled in a study entitled "treating abnormal postpartum uterine bleeding or postpartum hemorrhage with the jada system-a post-market registry".This report concerns 1 subject and 1 device.The subject's concurrent conditions included gestational hypertension and uterine atony, history included gravida 2 and para 2, live births 1, cesarean 1, uterine artery ligation and a therapeutic abortion.The subject's height was 156.2 centimeter (cm), weight was 68.7 kilogram (kg), body mass index (bmi) 28.16 (no units provided).On (b)(6) 2021, hemoglobin at admission was 14.7 (no units provided) and on (b)(6) 2021, at discharge was 10.5 (no units provided).The gestational age at delivery was 37.9 weeks.Type of labor was scheduled cesarean.Oxytocin was used at delivery at placenta for 4 hours post-delivery.On (b)(6) 2021 at 21:58, the subject had placental delivery of a singleton of weight 2470 grams, with no vaginal or cervical lacerations.Spinal anaesthesia was used.Uterine atony was present and a blood loss equal to 1300 (unit not reported) was noted.The interventions given prior to use of vacuum-induced hemorrhage control system (jada system) were 2 doses of carboprost, misoprostol, one dose of methylergometrine maleate (methergine), one dose of tranexamic acid (txa) and uterine artery ligation.On (b)(6) 2021 at 22:20, the vacuum-induced hemorrhage control system (jada system) was used for postpartum hemorrhage (lot and serial # were not provided).The total duration of vacuum-induced hemorrhage control system (jada system) indwelling time was 3.67 (units not reported).The total duration of vacuum-induced hemorrhage control system (jada system) admission to subject discharge from hospital was (b)(4) (units not reported).The total duration of vacuum-induced hemorrhage control system (jada system) removal to subject discharge from hospital was (b)(4) (units not reported).Total cumulative blood loss for the event 1500 (unit not reported).1 dose of carboprost was given during or after vacuum-induced hemorrhage control system (jada system).On (b)(6) 2022, the subject suffered with postpartum fever of unknown etiology (puerperal pyrexia) (mild) and treated with postpartum antibiotics like gentamicin and clindamycin which helped to resolve the fever on the same day.These antibiotics were also used as pre-operative drugs for cesarean delivery.After vacuum-induced hemorrhage control system (jada system) use, the subject was transfused with cell salvage 250 units for postpartum hemorrhage (pph).Therapy was withdrawn on (b)(6) 2021 at 02:00.The subject was discharged from the hospital on (b)(6)2021 at 14:15.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.Upon internal review, the event puerperal pyrexia was determined to be medically significant.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).Followup information has been received on (b)(6) 2022 as clarification.The indication for suspect product vacuum-induced hemorrhage control system (jada system) also included uterine atony.The route of administration was vaginal.The dechallege and rechallenge was not applicable.
 
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Brand Name
JADA SYSTEM
Type of Device
INTRAUTERINE VACUUM CONTRACTION SYSTEM
Manufacturer (Section D)
ALYDIA HEALTH
3495 edison way menlo park
menlo park
CA 94025
Manufacturer (Section G)
ALYDIA HEALTH
3495 edison way menlo park
menlo park
CA 94025
Manufacturer Contact
3495 edison way menlo park
menlo park
MDR Report Key15019717
MDR Text Key295955509
Report Number3017425145-2022-00116
Device Sequence Number1
Product Code OQY
UDI-Device Identifier00850017882003
UDI-Public(01)00850017882003
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberJADA-1001
Device Catalogue NumberJADA-1001
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/14/2022
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 Number1
Treatment
CARBOPROST.; CARBOPROST.; CLINDAMYCIN.; GENTAMICIN.; METHYLERGOMETRINE MALEATE (METHERGINE).; METHYLERGOMETRINE MALEATE (METHERGINE).; MISOPROSTOL.; MISOPROSTOL.; OXYTOCIN.; TRANEXAMIC ACID (TXA).; TRANEXAMIC ACID (TXA).
Patient Outcome(s) Other;
Patient Age38 YR
Patient SexFemale
Patient Weight68 KG
Patient EthnicityNon Hispanic
Patient RaceAsian
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