MAUDE Adverse Event Report: ORGANON LLC JADA SYSTEM; INTRAUTERINE TAMPONADE BALLOON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Fever (1858); Hemorrhage/Bleeding (1888); Laceration(s) (1946); Muscle Weakness (1967)

Event Date 09/15/2022

Event Type  Injury  

Event Description

The patient had pre t2dm (type 2 diabetes) on metformin & insulin, chtn (chronic hypertension), hypothyroidism, bmi 45.She was induced, then had ruptured membranes for greater than 30hrs requiring a cesarean section /b uterine atony & pph (postpartum hemorrhage) qbl (quantitative blood loss) 2800 cc requiring txa (tranexamic acid), extra pitocin, buccal cytotec, methergine.B- lynch suture, jada placed 1730p, 3u prbc (packed red blood cells), colloids & crystalloids.Intraop received 1 dose each iv azithromycin & ancef.Jada d/c next day 0830.She spiked a fever x2, given abx (antibiotics) x24hr then d/c.She was d/c (discharged) home with po macrobid.She then presented four days later dx (diagnosed) with uterine and incisional abscess, requiring total abdominal hysterectomy.

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): ORGANON LLC; 30 hudson street; floor 33; jersey city NJ 07302
• MDR Report Key: 16129885
• MDR Text Key: 307001453
• Report Number: 16129885
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/06/2023,01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 87 KG