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

Model Number JADA-1001

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Despite the report that jada seemed clotted, jada successfully treated this patient's postpartum hemorrhage.It is unclear whether the jada malfunctioned based on the information that is available at this time, but out of an abundance of caution and because we cannot rule it out at this time, we are reporting this event due to the 30-day reporting deadline.If we become aware of additional information, we will supplement this report.The submission of this report is not an admission that the device caused or contributed to the reported event.

Event Description

Jada was reported as working to treat atony and bleeding and the patient was then transported to the or to treat a 4th degree vaginal laceration.For transport, jada was left in place, and was disconnected from vacuum tubing and the tubing was placed under the patient's leg.Upon reconnection to vacuum in the or, no additional blood flow was observed through jada and it was suspected that the device or tubing may have become clotted.No escalation of care was necessary, but jada use was discontinued after this was discovered.

• 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: richard ferrick ; 3495 edison way; menlo park, CA 94025 ; 8445232666
• MDR Report Key: 11868797
• MDR Text Key: 252202060
• Report Number: 3017425145-2021-00009
• 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: 05/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/23/2021
• 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
• Patient Age: 30 YR
• Patient Weight: 79