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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 initial spontaneous report originating from the united states was received from a physician via employee referring to a female patient of unknown age.Patient delivered twins on an unknown date in (b)(6) 2022 (reported as approximately 2 weeks ago) (unknown delivery method).Information regarding the patient's other medical history, concurrent conditions and concomitant medications were not provided.This report concerns 1 device and 1 patient.On an unknown date in (b)(6) 2022, the patient was inserted with vacuum-induced hemorrhage control system (jada system) via vaginal route (lot# and expiration date were not reported) for post-partum hemorrhaging.Employee stated that vacuum-induced hemorrhage control system (jada system) was unable to control bleeding (device ineffective) as they "could not get the device to stay in place" (device expulsion).After vacuum-induced hemorrhage control system (jada system) was removed, bakri balloon (also reported as bakri uterine balloon) was inserted.Employee had extremely limited details and had reached out to the customer via email for additional details.No additional information available at that time.The availability of vacuum-induced hemorrhage control system (jada system) was unknown.The event device ineffective was considered as serious as it required intervention with an escalating treatment.Upon internal review, the event of "device expulsion" was determined to be medically significant.Medical device reporting criteria: serious injury.Fda code: (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
3495 edison way menlo park
MDR Report Key15210163
MDR Text Key297702593
Report Number3017425145-2022-00132
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,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 NumberJADA-1001
Device Catalogue NumberJADA-1001
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/29/2022
Initial Date FDA Received08/11/2022
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 Outcome(s) Other;
Patient SexFemale
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