MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FLOSEAL HEMOSTATIC MATRIX; ABSORBABLE COLLAGEN HEMOSTATIC AGENT WITH THROMBIN

Model Number	ADS202105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The patient underwent a lower spinal procedure with ¿hardware implanted¿ (with ¿trips back to the operating room for hardware replacement) wherein floseal hemostatic matrix was applied.The patient received unspecified pre and post operative antibiotics.The patient was discharged from the hospital without any issues with follow up care with the physician.Approximately six to eight weeks post operatively, the patient visited the physician, and the ¿source of surgery¿ was noted to be infected.Blood cultures were performed and were positive for candida albicans.It was not reported what from of medical intervention was provided.No further information was available at the time of this report.
Additional Manufacturer Narrative
H11: the actual device was not available; however, a companion sample was received for evaluation.A visual inspection was performed via the naked eye revealing that the kit box and the two pouches inside were sealed.The kit box packaging and seal integrity of the pouches were found to be intact, which did not identify any abnormalities that could have contributed to the reported condition.The set underwent functional testing by reconstituting the floseal product per the ifu and the entire set performed according to product specifications.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• 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 ; 2242702068
• MDR Report Key: 21185857
• Report Number: 1416980-2025-00110
• Device Sequence Number: 19908408
• Product Code: PMX
• UDI-Device Identifier: 00085412827957
• UDI-Public: (01)00085412827957(10)HA24061X(17)251204
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2025
• Device Model Number: ADS202105
• Device Catalogue Number: ADS202105
• Device Lot Number: HA24061X
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male