MAUDE Adverse Event Report: GI SUPPLY JADA System; INTRAUTERINE TAMPONADE BALLOON

Model Number	JADA 2.0 DEVICE USA ORG
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/01/2026
Type of Reportable Event	Death
Event or Problem Description
Vaginal delivery with post-partum hemorrhage requiring jada intervention.There was bleeding around jada which prompted removal, at which time cervical laceration was noted.Laceration was repaired and transfusion protocols were implemented.Patient was transferred to the icu where an additional transfusion protocol was initiated post-hysterectomy.Patient died during admission.No additional details known/reported.
Additional Manufacturer Narrative
The model number information was not reported or not known by the reporter.Hence, we cannot definitively determine the model with the information provided.If any additional information becomes available, and additional report may be submitted.

• Brand Name: JADA System
• Common Device Name: INTRAUTERINE TAMPONADE BALLOON
• Manufacturer (Section D): GI SUPPLY; 5069 ritter road; suite 104; mechanicsburg PA 17055
• Manufacturer (Section G): GI Supply; 5069 ritter road; suite 104; mechanicsburg PA 17055
• Manufacturer Contact: zulmar molina ; 5069 ritter road; suite 104; mechanicsburg, PA 17055
• MDR Report Key: 50510205
• Report Number: 3017448360-2026-00004
• Device Sequence Number: 9309813
• Product Code: OQY
• UDI-Device Identifier: 00893029002762
• UDI-Public: 00893029002762
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K253642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: JADA 2.0 DEVICE USA ORG
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/29/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown