FLOSEAL MATRIX HEMOSTATIC SEALANT FR0002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-09 for FLOSEAL MATRIX HEMOSTATIC SEALANT FR0002 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[17726702] Pt b: according to the reporter: a gyn surgeon at hosp circulated an email to her colleagues asking them if they had seen any incidence of tubal ovarian abscess in their postoperative ovarian cystectomy pts in whom they had used floseal. The surgeon had seen 2 in the past few days/weeks and was looking for additional experiences. Reporter did not have any pt info to share and assured me that, in her opinion, this was not a serious situation. Baxter rn, asked reporter to notify the surgeon that she had spoken to her and that baxter was very interested in obtaining additional info. Reporter assured baxter rn that she would speak to the surgeon and tell her of baxter's responsiveness and interest in this concern.
Patient Sequence No: 1, Text Type: D, B5


[18013373] Baxter med dir assessment: february 14, 2007. For the medical evaluation following clinical details are required: diagnosis and indication for surgery; potential perioperative risk factors for infection (diabetes, intraoperative contamination, duration of surgery); course and outcome of infection, including confirmatory tests for abscess; lot number in both reported cases; similar adverse events with the same lot number; application method: excess of floseal removed or not, volume applied. A medical causality assessment is not possible based on the existing data. Multiple attempts have been made to acquire additional info regarding this case with no response from the nurse. If any further info comes available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2954761-2007-00005
MDR Report Key827750
Report Source05
Date Received2007-03-09
Date of Report2007-03-09
Date of Event2007-02-09
Date Mfgr Received2007-02-09
Date Added to Maude2007-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJOSHUA LEACH, SPECIALIST
Manufacturer StreetONE BAXTER WAY
Manufacturer CityWESTLAKE VILLAGE CA 91362
Manufacturer CountryUS
Manufacturer Postal91362
Manufacturer Phone8053723250
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLOSEAL MATRIX HEMOSTATIC SEALANT
Generic NameHEMOSTATIC SEALANT
Product CodeEBC
Date Received2007-03-09
Model NumberFR0002
Catalog NumberFR0002
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key815155
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer Address34175 ARDENWOOD BLVD. FREMONT CA 94555 US
Baseline Brand NameFLOSEAL MATRIX HEMOSTATIC SEALANT
Baseline Generic NameDEVICES
Baseline Model NoFR0002
Baseline Catalog NoFR0002
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2007-03-09

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