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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNSTAR AMERICAS PAROEX; CHLORHEXIDINE GLUCONATE
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SUNSTAR AMERICAS PAROEX; CHLORHEXIDINE GLUCONATE Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 08/10/2020
Event Type  malfunction  
Event Description
On 10/28/2020 the fda sent out a recall for sunstar chlorhexidine gluconate oral rinse due to bacteria burkholderia lata.This product was used at the hospital between july and october 2020.There are 11 patients who had positive cultures for bacteria burkholderia cepacia.Each of the patients involved had thorough investigations.Patients were treated as appropriate by their physicians.The positive cultures were reported through (b)(6) as warranted as well as to the local department of health.Fda has also been alerted.Appropriate patient notification has been accomplished.All affected inventory has been discarded.
 
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Brand Name
PAROEX
Type of Device
CHLORHEXIDINE GLUCONATE
Manufacturer (Section D)
SUNSTAR AMERICAS
301 east central road
schaumburg IL 60195
MDR Report Key10894207
MDR Text Key217964502
Report Number10894207
Device Sequence Number1
Product Code NTO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2020
Event Location Hospital
Date Report to Manufacturer11/24/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/24/2020
Type of Device Usage Unknown
Patient Sequence Number1
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