FDA Adverse Event Malfunction Summary report: N

7062705

MDR report key: 7062705 · Received November 28, 2017

Report

Report Number
7062705
Event Type
Malfunction
Date Received
November 28, 2017
Date of Event
July 31, 2017
Report Date
November 27, 2017
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MD, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE FOLLOWING ELEMENTS HAVE BLANK DATA.

Additional Manufacturer Narrative · 1

THE FOLLOWING ELEMENTS HAVE BLANK DATA.

Description of Event or Problem · 1

A FEMALE PATIENT UNDERWENT GLIOMA SURGERY. SUBSEQUENTLY, CSF DRAWN FROM THE PATIENT WAS LEFT ON A COUNTER FOR AN EXTENDED PERIOD OF TIME IN THE PATIENT'S ROOM, AND CULTURED POSITIVE FOR BIPOLARIS.

Description of Event or Problem · 1

A (B)(6) FEMALE UNDERWENT GLIOMA SURGERY. SUBSEQUENTLY, CSF DRAWN FROM THE PATIENT WAS LEFT ON A COUNTER FOR AN EXTENDED PERIOD OF TIME IN THE PATIENT'S ROOM, AND CULTURED POSITIVE FOR BIPOLARIS.

Description of Event or Problem · 1

A (B)(6) FEMALE UNDERWENT GLIOMA SURGERY. SUBSEQUENTLY, CSF DRAWN FROM THE PATIENT WAS LEFT ON A COUNTER FOR AN EXTENDED PERIOD OF TIME IN THE PATIENT'S ROOM, AND CULTURED POSITIVE FOR BIPOLARIS.

Description of Event or Problem · 1

A (B)(6) FEMALE UNDERWENT GLIOMA SURGERY. SUBSEQUENTLY, CSF DRAWN FROM THE PATIENT WAS LEFT ON A COUNTER FOR AN EXTENDED PERIOD OF TIME IN THE PATIENT'S ROOM, AND CULTURED POSITIVE FOR BIPOLARIS.

Patients

Seq Age Sex Outcome Treatment
1 30 YR