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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 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 originating from united states was received from a physician and a nurse via a sales representative, referring to a female patient of unknown age.This report concerns 1 patient and 1 device.This patient was described as multiparous.She had a spontaneous vaginal delivery and her postpartum hemorrhage (pph) started within one hour after delivery.Hence, she received carboprost trometamol (hemabate) (1 unit), misoprostol (cytotec) (1 unit) and methylergometrine maleate (methergine) (1 unit).The patient's blood loss was reported as 1000 milliliter (ml).The patient was also treated with uterotonics (unspecified) for pph, however it failed.The cervical seal was reported as filled with 60 ml of sterile fluid.On (b)(6) 2022, the patient was inserted with vacuum-induced hemorrhage control system (jada system), however it did not control the pph bleeding (device ineffective), and due to which the patient received a dilation and curettage (d&c), attempted bakri, and b lynch suture.On (b)(6) 2022, the nurse reported that, they did not retain the device and lot number.Further she reported that, it was just an unfortunate event, and it there was no fault of the vacuum-induced hemorrhage control system (jada system).The decision to use the device was made late in the hemorrhage and the patient ended up going into d&c.The event of device ineffective was considered to be serious as an intervention was required (dilation and curettage (d&c).(b)(4).
 
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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 CA 94025
Manufacturer (Section G)
ALYDIA HEALTH
3495 edison way
menlo park CA 94025
Manufacturer Contact
heather wisler
3495 edison way
menlo park, CA 94025
8445232666
MDR Report Key14366355
MDR Text Key294673461
Report Number3017425145-2022-00084
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 Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/11/2022
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 NumberJADA - 1001
Device Catalogue NumberJADA-1001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/11/2022
Initial Date FDA Received05/11/2022
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 Number1
Patient SexFemale
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