*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-02 for * manufactured by *.

Event Text Entries

[58153] Admitted 4/25/97 for same day surgical procedure, underwent a hysteroscopy for reduction of uterine fibroid and ovarian cyst. Pt was put under general anesthesia and at 1300, procedure began. Initially, her blood pressures were approximately systolic of 100-110- with pulse in the 60's - 50's. At 1530, her bp decreased to systolic of 80's. At 1600, there was an abrupt desaturation and the procedure was ended. They had used 18 (3 liter) bags of glycine during procedure. In postop, recovery room, was slow to awaken and confused. Electrolytes at that time confirmed fluid overload and lasix was ordered. This caused a diuresis. Her serum sodium was then found to be 85mmol. She was moved to icu at 0130 on 4/26/97, pupils were noted to be fixed and dilated and she was unresponsive. Ct scan showed diffuse cerebral edema. Diagnosis made of hyponatremic encephalopathy with presumed cerebral herniation syndrome. Pt was declared clinically brain dead at 1530 on 4/30/97.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 88903
• MDR Report Key: 88903
• Date Received: 1997-05-02
• Date of Report: 1997-05-01
• Date of Event: 1997-04-25
• Date Facility Aware: 1997-04-25
• Report Date: 1997-05-01
• Date Reported to FDA: 1997-05-01
• Date Reported to Mfgr: 1997-05-01
• Date Added to Maude: 1997-05-07
• 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
• Reporter Occupation: RISK MANAGER
• 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: *
• Generic Name: 1.5% GLYCINE IRRIGATION, USP
• Product Code: LTA
• Date Received: 1997-05-02
• Model Number: *
• Catalog Number: *
• Lot Number: UNK
• ID Number: *
• Device Availability: *
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 87908
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1997-05-02