QUIDEL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-10 for QUIDEL * manufactured by Quidel.

Event Text Entries

[48434] Baby boy was delivered at this facility and became ill soon after delivery (respiratory distress). Baby was transferred from this facility to a higher level neonate unit of another facility in the same city. Baby expired during the night.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 82500
• MDR Report Key: 82500
• Date Received: 1997-04-10
• Date of Report: 1997-04-09
• Date of Event: 1997-03-18
• Date Facility Aware: 1997-03-19
• Report Date: 1997-04-07
• Date Reported to FDA: 1997-04-10
• Date Reported to Mfgr: 1997-04-09
• Date Added to Maude: 1997-04-11
• 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: MEDICAL TECHNOLOGIST
• 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: QUIDEL
• Generic Name: GBS KIT
• Product Code: GTY
• Date Received: 1997-04-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Expiration Date: 1997-08-22
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 7 DAY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 81890
• Manufacturer: QUIDEL
• Manufacturer Address: 10165 MCKELLAR CT. SAN DIEGO CA 92121 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1997-04-10