AQUASONIC 100 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-20 for AQUASONIC 100 * manufactured by Parker Laboratories, Inc..

Event Text Entries

[2056964] A female child had a left retroperitoneal ganglioneuroma which was partially removed. A ureteral stent was placed at the time of surgery. The tumor was benign. She was seen in clinic for an ultrasound (us) to evaluate the mass. After the us, she complained of itchiness and redness in the area where the us was performed. Later in the day, she developed hives in the same area. We have no information about follow up care for the hives.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2137129
• MDR Report Key: 2137129
• Date Received: 2011-06-20
• Date of Report: 2011-06-20
• Date of Event: 2011-06-14
• Report Date: 2011-06-20
• Date Reported to FDA: 2011-06-20
• Date Added to Maude: 2011-06-22
• 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: 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 Sequence Number: 1

• Brand Name: AQUASONIC 100
• Generic Name: ULTRASOUND TRANSMISSION GEL
• Product Code: GYB
• Date Received: 2011-06-20
• Model Number: *
• Catalog Number: *
• Lot Number: C691
• ID Number: *
• Operator: OTHER
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PARKER LABORATORIES, INC.
• Manufacturer Address: 286 ELDRIDGE RD FAIRFIELD NJ 07004 US 07004

Device Sequence Number: 2

• Brand Name: T-SPRAY II
• Generic Name: DISINFECTANT USED TO CLEAN US PROBE
• Product Code: LRJ
• Date Received: 2011-06-20
• Model Number: *
• Catalog Number: 610-703
• Lot Number: *
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CIVCO MEDICAL SOLUTIONS
• Manufacturer Address: 102 FIRST ST. SOUTH KALONA IA 52247 US 52247

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-06-20