AMINIOSTAT-FLM * D101-006

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-05-22 for AMINIOSTAT-FLM * D101-006 manufactured by Irvine Scientific.

Event Text Entries

[324592] Two different pts got two different results from two kits. Both developed respiratory problems and had to be transported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028529
• MDR Report Key: 462617
• Date Received: 2003-05-22
• Date of Report: 2003-05-22
• Date of Event: 2003-05-21
• Date Added to Maude: 2003-06-02
• Event Key: 0
• Report Source Code: Voluntary 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: AMINIOSTAT-FLM
• Generic Name: LAB TESTING DEVICE
• Product Code: JHG
• Date Received: 2003-05-22
• Model Number: *
• Catalog Number: D101-006
• Lot Number: A621013
• ID Number: *
• Device Expiration Date: 2003-07-31
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 451566
• Manufacturer: IRVINE SCIENTIFIC
• Manufacturer Address: 2511 DAIMLER SANTA ANA CA 92705 US

Device Sequence Number: 2

• Brand Name: AMINIOSTAT-FLM
• Generic Name: LAB TESTING DEVICE
• Product Code: JHG
• Date Received: 2003-05-22
• Model Number: *
• Catalog Number: D101-006
• Lot Number: A620912
• ID Number: *
• Device Expiration Date: 2003-06-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 451569
• Manufacturer: IRVINE SCIENTIFIC
• Manufacturer Address: 2511 DAIMLER SANTA ANA CA 92705 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-05-22