FDA Adverse Event Malfunction Summary report: N

DUREPAIR®

MDR report key: 7250873 · Received February 8, 2018

Report

Report Number
7250873
Event Type
Malfunction
Date Received
February 8, 2018
Date of Event
March 27, 2017
Report Date
January 31, 2018
Manufacturer
MEDTRONIC MEDICAL, INC.
Product Code
GXQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PATIENT HAD MENINGIOMA REMOVED, SUBSEQUENTLY HAD AN INFECTION (B)(6), REQUIRED TWO ADDITIONAL PROCEDURES. PATIENT RELAYED THAT SHE IS CONCERNED ABOUT THE 2 INFECTIONS THAT SHE DEVELOPED 20 DAYS POST-SURGERY. SHE WAS TOLD BY INFECTION CONTROL THAT THIS LIKELY WAS ACQUIRED DURING HER FIRST SURGERY AND THE REASON FOR DELAYED SYMPTOMS WAS BECAUSE THE INFECTION HAD TO GROW FROM THE INSIDE FIRST BEFORE SHOWING OUTWARD SYMPTOMS. SHE HAS CONCERNS THAT THE BOVINE MEMBRANE IMPLANT WAS CONTAMINATED, OR THAT SOMEHOW DURING THE SURGERY SHE ACQUIRED TWO DIFFERENT BACTERIA THAT CAUSED INFECTION (WHICH THEN REQUIRED TWO ADDITIONAL SURGERIES). AS SHE HAS WORKED FOR (B)(6), SHE IS AWARE THAT SHOULD THIS PROVE TO BE CONTAMINATED THAT THERE WOULD LIKELY BE FDA INVESTIGATION LAUNCHED. SHE IS HOPING TO BRING THIS TO ATTENTION AND HOPEFULLY PREVENT THIS FROM HAPPENING TO ANOTHER PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
99844 DUREPAIR® DURA SUBSTITUTE GXQ MEDTRONIC MEDICAL, INC. 62105 1608002

Patients

Seq Age Sex Outcome Treatment
1 53 YR Other