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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALYDIA HEALTH, INC. JADA SYSTEM; INTRAUTERINE TAMPONADE BALLOON
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ALYDIA HEALTH, INC. JADA SYSTEM; INTRAUTERINE TAMPONADE BALLOON Back to Search Results
Catalog Number JADA-1001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rupture (2208)
Event Date 01/03/2022
Event Description
Patient s/p cesarean section delivery.Patient with hypotension and post -partum hemorrhage prior to leaving operating room.Jada device placed and patient stabilized.Patient transferred to sicu and subsequently with need for return to surgery.Patient with a supracervical hysterectomy after finding posterior uterine rupture.Unsure if jada device involved in complication.Fda safety report id# (b)(4).
 
Event Description
Patient s/p cesarean section delivery.Patient with hypotension and post-partum hemorrhage prior to leaving operating room.Jada device placed and patient stabilized.Patient transferred to sicu and subsequently with need for return to surgery.Patient with a supracervical hysterectomy after finding posterior uterine rupture.Unsure if jada device involved in complication.Fda safety report id # (b)(4).
 
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Brand Name
JADA SYSTEM
Type of Device
INTRAUTERINE TAMPONADE BALLOON
Manufacturer (Section D)
ALYDIA HEALTH, INC.
menlo park CA
MDR Report Key13542763
MDR Text Key285768107
Report NumberMW5107477
Device Sequence Number1
Product Code OQY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberJADA-1001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age35 YR
Patient SexFemale
Patient Weight119 KG
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