BEHRING FIBRINTIMER A * OVSB03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-01 for BEHRING FIBRINTIMER A * OVSB03 manufactured by Behring Diagnostic, Inc..

Event Text Entries

[74376] Pt admitted to hosp for abdominal pain on 5/18/96. Because of severe pain ct of abdomen done and revealed portal vein thrombosis involving the splenic and superior mesenteric veins. Pt was started on heparin and tpa (tissue plasminogen activator). Labs drawn 5/19/96 1814 for ptt were reported back at 7160. Due to this, pt's heparin was stopped, tpa continued. When corrected lab value reported, the heparin was restarted at a higher dose. Pt was discharged 6/3/96.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 129668
• MDR Report Key: 129668
• Date Received: 1997-07-01
• Date of Report: 1996-06-18
• Date of Event: 1996-05-19
• Date Facility Aware: 1996-05-30
• Report Date: 1996-06-18
• Date Added to Maude: 1997-11-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BEHRING FIBRINTIMER A
• Generic Name: COAGULATION INSTRUMENT
• Product Code: GKT
• Date Received: 1997-07-01
• Model Number: *
• Catalog Number: OVSB03
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: 42 DAY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 126826
• Manufacturer: BEHRING DIAGNOSTIC, INC.
• Manufacturer Address: 3403 YERBA BUENA RD. SAN JOSE CA 951619013 US

Device Sequence Number: 2

• Brand Name: REAGENT PATHROMPTIN
• Generic Name: REAGENT
• Product Code: GIT
• Date Received: 1997-07-01
• Model Number: *
• Catalog Number: OQ65
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: 42 DAY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 126827
• Manufacturer: BEHRING DIAGNOSTIC, INC.
• Manufacturer Address: 3403 YERBA BUENA RD. SAN JOSE CA 951619013 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	1997-07-01