SERAFLO TRANSDUCER PROTECTOR * 0492025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-24 for SERAFLO TRANSDUCER PROTECTOR * 0492025 manufactured by Althin Medical, Inc..

Event Text Entries

[18552942] Facility alleges transducer protector clotted off causing the venous blood line to clot off. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2243621-1996-04956
• MDR Report Key: 101200
• Date Received: 1996-04-24
• Date of Report: 1996-01-17
• Date of Event: 1993-12-17
• Date Facility Aware: 1993-12-17
• Report Date: 1996-01-17
• Date Added to Maude: 1997-06-30
• Event Key: 0
• Report Source Code: Distributor 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 Details

• Brand Name: SERAFLO TRANSDUCER PROTECTOR
• Generic Name: *
• Product Code: FIB
• Date Received: 1996-04-24
• Model Number: *
• Catalog Number: 0492025
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 99701
• Manufacturer: ALTHIN MEDICAL, INC.
• Manufacturer Address: P.O. BOX 360156M PITTSBURGH PA 15251 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-04-24