HP *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-10 for HP * manufactured by Hewlett-packard Co. Medical Products Group.

Event Text Entries

[165048] Blister noted at previously used tcm sige after patch was removed on three day old infant.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015914
• MDR Report Key: 214817
• Date Received: 1999-03-10
• Date of Report: 1999-03-09
• Date of Event: 1999-02-10
• Date Added to Maude: 1999-03-22
• 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: RISK MANAGER
• 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 Details

• Brand Name: HP
• Generic Name: HP TCP CO2/TCPO2
• Product Code: KLK
• Date Received: 1999-03-10
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 208386
• Manufacturer: HEWLETT-PACKARD CO. MEDICAL PRODUCTS GROUP
• Manufacturer Address: 3000 MINUTEMAN RD. ANDOVER MA 018101099 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-03-10