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

Model Number JADA - 1001

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The lot number is not currently available for this event.We have attempted to request this information from the health care provider, no response to follow up attempts to date.A good faith effort to obtain lot number has been attempted.The device labeling states the indication for use of jada is "to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted." precautions state, "the safety and effectiveness of the use of jada in patients with placenta accreta have not been evaluated." the instructions for use state, "jada placement: post vaginal delivery or post cesarean section after closure of hysterotomy.Secure visualization of the cervix to confirm it is dilated greater than 3 cm to allow for placement of jada." based on the overall information currently available for this case, a possible contributing or causal role of the jada system to the occurrence of the event (reported as "jada was not successful") cannot be excluded.However, the limited information provided with respect to the clinical details of the event precludes a complete and meaningful assessment.This report may be amended as appropriate if additional information is received regarding the event.

Event Description

On (b)(6) 2022, an alydia health employee had a conversation with a friend who is an obstetrician, who reported that she had an opportunity to use a jada device for the first time and "jada was not successful." she went on to say that the patient in this case had undiagnosed placenta accreta and was only 8 cm dilated.The patient had a medical history of a previous cesarean section.She indicated that she had not been trained on jada use and was "unaware of the need to be 10 cm dilated but was now aware of this." it was not reported where she received this information from.There was no other information that was provided for this case.

Manufacturer Narrative

The lot number is not currently available for this event.We have attempted to request this information from the health care provider, no response to follow up attempts to date.A good faith effort to obtain lot number has been attempted.The device labeling states the indication for use of jada is "to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted." precautions state, "the safety and effectiveness of the use of jada in patients with placenta accreta have not been evaluated." the instructions for use state, "jada placement: post vaginal delivery or post cesarean section after closure of hysterotomy.Secure visualization of the cervix to confirm it is dilated greater than 3 cm to allow for placement of jada." based on the overall information currently available for this case, a possible contributing or causal role of the jada system to the occurrence of the event (reported as "jada was not successful") cannot be excluded.However, the limited information provided with respect to the clinical details of the event precludes a complete and meaningful assessment.This report may be amended as appropriate if additional information is received regarding the event.

Event Description

On (b)(6) 2022, an alydia health employee had a conversation with a friend who is an obstetrician, who reported that she had an opportunity to use a jada device for the first time and "jada was not successful." she went on to say that the patient in this case had undiagnosed placenta accreta and was only 8 cm dilated.The patient had a medical history of a previous cesarean section.She indicated that she had not been trained on jada use and was "unaware of the need to be 10 cm dilated but was now aware of this." it was not reported where she received this information from.There was no other information that was provided for this case.

• 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 Key: 13506615
• MDR Text Key: 286085025
• Report Number: 3017425145-2022-00007
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• 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
• Patient Age: 30 YR
• Patient Sex: Female