HYPAQUE 60% *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-26 for HYPAQUE 60% * manufactured by Unk.

Event Text Entries

[20244681] Hives following contrast infusion. Benadryl 50mg im given. Prior h/ hives following contrast that pt remembered after reaction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1009801
• MDR Report Key: 35903
• Date Received: 1996-08-26
• Date of Report: 1996-08-12
• Date of Event: 1996-08-12
• Date Added to Maude: 1996-08-28
• 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: RADIOLOGIC TECHNOLOGIST
• 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: HYPAQUE 60%
• Generic Name: CONTRASTING DYE
• Product Code: KTA
• Date Received: 1996-08-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: UNKNOWN
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 37325
• Manufacturer: UNK
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		1996-08-26