SONIC GENERIC ULTRASOUND TRANSMISSION GEL UNK REF P11111-05

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-21 for SONIC GENERIC ULTRASOUND TRANSMISSION GEL UNK REF P11111-05 manufactured by Pharmaceutical Innovations, Inc.

Event Text Entries

[480278] Infection control noted that nicu babies with positive cultures for pseudomonas had all gone for echocardiograms. Investigation lead to culturing the gel. Ultrasound gel comes in 5 liter containers with 8 oz refillable bottles. Bottles are topped off and not capped. 8 oz bottles and 5 liter bottles tested positive for the pseudomonas organism. A new unopened container was sent out for culture - results are pending. Four areas of the hospital use the refillable bottles, the rest of the hospital buys the 8 oz bottle. Infection control discourages topping off any fluids. It is not known for sure if the ultrasound gel was the source of the nicu babies' infections as it is a common organism. Investigation and testing is ongoing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 740449
• MDR Report Key: 740449
• Date Received: 2006-07-21
• Date of Report: 2006-07-21
• Date of Event: 2006-07-21
• Report Date: 2006-07-21
• Date Reported to FDA: 2006-07-21
• Date Added to Maude: 2006-07-27
• 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: SONIC GENERIC ULTRASOUND TRANSMISSION GEL
• Generic Name: GEL, ULTRASOUND
• Product Code: MUI
• Date Received: 2006-07-21
• Model Number: UNK
• Catalog Number: REF P11111-05
• Lot Number: 122163
• ID Number: *
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 728318
• Manufacturer: PHARMACEUTICAL INNOVATIONS, INC
• Manufacturer Address: 897 FRELINGHUYSEN AVE NEWARK NJ 071142195 US

Device Sequence Number: 2

• Brand Name: SONIC GENERIC ULTRASOUND TRANSMISSION GEL
• Generic Name: GEL, ULTRASOUND
• Product Code: MUI
• Date Received: 2006-07-21
• Model Number: UNK
• Catalog Number: REF P11111-05
• Lot Number: 122105
• ID Number: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 728319
• Manufacturer: PHARMACEUTICAL INNOVATIONS, INC.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention	2006-07-21