FLOSEAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for FLOSEAL manufactured by Baxter Healthcare Corporation.

Event Text Entries

[182216964] Under general anesthesia, the patient was placed in the prone position. After adequate padding of bony protuberances, the back was prepped and draped in the usual sterile fashion. Skin over the midline spine was infiltrated with a solution of epinephrine. Midline incision was made. This was brought down to the hardware bilaterally. There was no obvious large abscess noted on either side of the spine. At the l3-4 level on the right, which was where the sinogram appeared to have connections, there looked to be some biofilm on the rod, the biofilm was cultured, and then when all the hardware was removed, i re-cultured the hardware bed and the screw hold at l3-4 on the right. Once all the hardware was removed, pseudoarthrosis was found between 1 and 2, the rest of the spine looked relatively stable. Large curettes were used to curette the bed where the hardware was, this caused some bleeding. After the cultures were obtained and bone biopsy was obtained, 3 l of p pulsatile irrigation were used to clean the wound. The wound was packed off with some floseal to help control bleeding, but due to kind of raw edges, it did bleed a fair amount. Two large drains were used to drain each side of the wound deeply. These were sewn in. The fascia was closed with interrupted 0, and then horizontal prolene mattress sutures. Dr. (b)(6) then entered the room where she had this flank abscess. This was opened up wider by dr. (b)(6), and then a wound vac was placed over her flank wounds (please see dr. (b)(6)'s note for details concerning the insertion of the wound vac. The patient was then woken up and returned to recovery room in stable condition. The patient had been in the prone position, prepped and draped in standard sterile fashion per dr. (b)(6). At the completion of his case, i probed the medial wound that extended to the posterior iliac crest and had a rather large extensive cavity. This did not communicate with the inferior older sinus tract. This tract was opened up and incised approximately 2 inches and then a piece of granufoam was inserted into this area to the side of the indurated area. The inferior sinus tract was also opened about 2 inches and did not communicate with that more superior cavity, but was opened enough so that one granufoam sponge could be placed. The 2 granufoam sponges were bridged and then the occlusive dressing was applied with a wound vac at 125 continuous low suction. The patient tolerated the procedure well. Further care per dr. (b)(6) and team. Wound vac dressing changes will be done on monday, wednesday, and fridays or the tuesday after christmas. This was discussed with dr. (b)(6) and eventually the patient's husband. I have reviewed the fda maude adverse event report referenced above and find baxter's response evasive. While i previously detailed the event information, i have attached the hospital's surgical notes for your reference so there is no confusion! Again - how many people have to be injured or die before something is done? Re: mdr report key (b)(4). Report # 1416980-2020-00028. Floseal - baxter.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093405
MDR Report Key9774781
Date Received2020-02-28
Date Added to Maude2020-03-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLOSEAL
Generic NameAGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
Product CodeLMF
Date Received2020-02-28
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.