FDA Adverse Event Malfunction Summary report: N

PURASTAT

MDR report key: 23555783 · Received November 14, 2025

Report

Report Number: 3012263097-2025-00001
Event Type: Malfunction
Date Received: November 14, 2025
Date of Event: August 15, 2025
Report Date: November 14, 2025
Manufacturer: 3-D MATRIX EUROPE SAS
Product Code: QAU
UDI-DI: 04560436590354
PMA / PMN Number: K242250
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ME, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE REPORT IS BEING SUBMITTED BASED ON THE INFORMATION CURRENTLY AVAILABLE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED TO DATE. DEVICE EVALUATION COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

Description of Event or Problem · 0

MANUFACTURER RECEIVED A MEDWATCH REPORT DESCRIBING A DEVICE MALFUNCTION DURING PATIENT USE. EVENT DESCRIPTION FROM HEALTH PROFESSIONAL: DESCRIBE THE EVENT OR PROBLEM: PATIENT WAS AN ACTIVE BLEED DURING THE PROCEDURE RECEIVING BLOOD TRANSFUSION. MULTIPLE TYPES OF INTERVENTION WERE DONE AND THE PURA STAT WAS DELAYING CARE. A SECOND SYRINGE OF PURA STAT WAS USED WITHOUT DIFFICULTY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? EGD. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2786051	PURASTAT	HEMOSTATIC DEVICE	QAU	3-D MATRIX EUROPE SAS	621-035	23B23A30	04560436590354

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR	Male	Other