*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-19 for * manufactured by Unk.

Event Text Entries

[17245076] Admitted for elective termination of pregnancy due to suspected nonviability of fetus. In physician's office prior to admission, laminaria were placed after informed consent received. On admission, misoprostol was administered with spontaneous rupture of membranes a few hours later. Later the pt had respiratory distress which required intubation. Finally arrested and expired. Autopsy by coroner states "cause of death: disseminated intravascular coagulation secondary to probable clostridium sepsis". "microscopic diagnosis: necrotizing endomyometritis secondary to clostridium infection, bacteria also in placenta. "
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 539786
• MDR Report Key: 539786
• Date Received: 2004-04-19
• Date of Report: 2003-09-01
• Date of Event: 2003-07-01
• Date Added to Maude: 2004-08-20
• 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: 3
• 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: LAMINARIA
• Product Code: HDY
• Date Received: 2004-04-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 529090
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2004-04-19