MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLOSEAL HEMOSTATIC MATRIX; Absorbable collagen hemostatic agent with thrombin

Model Number	ADS201844
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: FLOSEAL HEMOSTATIC MATRIX
• Common Device Name: Absorbable collagen hemostatic agent with thrombin
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50810467
• Report Number: 1416980-2026-02984
• Device Sequence Number: 15616571
• Product Code: PMX
• UDI-Device Identifier: 00085412639598
• UDI-Public: (01)00085412639598(17)280221(10)HA260381
• Combination Product (Y/N): Y
• Initial Reporter State: NA
• Initial Reporter Country: SF
• PMA/510(K) Number: P990009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: Other
• Device Model Number: ADS201844
• Device Catalogue Number: ADS201844
• Device Lot Number: HA260381
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown