OTHER-SONIC NDC 36-1111-25 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-02 for OTHER-SONIC NDC 36-1111-25 * manufactured by Pharmaceutical Innovations, Inc..

Event Text Entries

[2551311] In late december 2011, the department of epidemiology identified an increase in the number of patients undergoing surgery who developed colonization or infection with p. Aeruginosa. An immediate investigation was begun. The patients were localized to one unit, among patients undergoing cardiovascular surgery. Colonization/infection was confined to the respiratory tract. No surgical wound infections, device-associated infections, or bloodstream infections were identified. A total of 16 patients eventually were found to harbor p. Aeruginosa. The majority of cases were either asymptomatic (colonized) or had mild tracheobronchitis. Molecular typing of 10 case isolates were similar. Dates of onset were from early december, 2011 through mid-january of 2012. Cases were found to be more likely to have tee probes in place for longer periods of time than non-cases. Therefore, the tee probes were inspected and cultured - all culture results were negative. Since tee probes are inserted with an ultrasound transmission gel, the 250ml dispensers of "bacteriostatic" ultrasound transmission gel were removed from all or's as a precaution and replaced with single dose sterile ultrasound gel (pending culture results). After this intervention, no further cases developed. The 250ml dispensers of "bacteriostatic" other-sonic ultrasound gel manufactured by pharmaceutical innovations, inc. , newark, nj (ref #ndc 36-1111-25) were cultured and found to harbor various organisms including p. Aeruginosa matching the case strain by molecular typing. Unopened bottles of other-sonic gel were cultured as well to exclude intrinsic contamination. At least 2 of the sealed bottles are growing microorganisms (presumptively, p. Aeruginosa) to date. The hospital has internally recalled the other-sonic gel in question in mid-february of 2012.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2484371
MDR Report Key2484371
Date Received2012-03-02
Date of Report2012-03-02
Date of Event2012-02-15
Report Date2012-03-02
Date Reported to FDA2012-03-02
Date Added to Maude2012-03-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameOTHER-SONIC
Generic NameMEDIA, COUPLING, ULTRASOUND
Product CodeMUI
Date Received2012-03-02
Model NumberNDC 36-1111-25
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerPHARMACEUTICAL INNOVATIONS, INC.
Manufacturer Address897 FRELINGHUYSEN AVENUE NEWARK NJ 07114 US 07114


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2012-03-02

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