FDA.reportPublic FDA data

MAUDE MDR 3452861

MDR report key
3452861
Report number
1056553-2013-00001
Event key
0
Event type
3
Date received
2013-10-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CHRISTOPHER BROWN
Address
6830 MEADOWRIDGE CT. ALPHARETTA GA 30005 US
Phone
770-770-7708
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REMINGTON MEDICALAUTOMATIC CUTTING NEEDLEREMINGTON MEDICAL, INC.KNWNAC-1825BNAC-1825B130646R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-10-2501. R

Event Narratives#

D

Patient 1

A PHYSICIAN HAD BEEN PROVIDED THREE (3) REMINGTON MEDICAL NAC-1825B BIOPSY NEEDLES TO TRY OUT ON PROSTATE BIOPSY PROCEDURES. AFTER USE, THE PHYSICIAN CONTACTED REMINGTON MEDICAL VIA E-MAIL ON (B)(6) 2013 AND REPORTED: "2 PTS BECAME SEPTIC DESPITE TREATING THEM ALL THE SAME WAY I DID 12 BXS ALL DID WELL BUT THESE TWO." REMINGTON MEDICAL REQUESTED CLARIFICATION SINCE THE STATEMENT APPEARED TO SUGGEST THAT THE PHYSICIAN PERFORMED BIOPSIES ON TWELVE (12) PATIENTS WITH THESE NEEDLES, MEANING HE WOULD HAVE HAD TO USE THE SINGLE-USE NEEDLES ON MULTIPLE PATIENTS. HIS RESPONSE STATED: "BOTH PATIENTS (2) HAD 12 CORE BIOPSIES. BOTH HAD E. COLI UROSEPSIS DESPITE PROPHYLACTIC ANTIBIOTIC, PRE-OP AND PERI-OP ANTIBIOTICS." E. COLI IS A VERY COMMON BACTERIA IN HUMAN GASTROINTESTINAL SYSTEMS, AND SINCE PROSTATE BIOPSIES ARE CONDUCTED VIA RECTAL ACCESS, THIS TYPE OF INFECTION IS POSSIBLE.

N

Patient 1

E. COIL IS A VERY COMMON BACTERIA IN HUMAN GASTROINTESTINAL SYSTEMS, AND SINCE PROSTATE BIOPSIES ARE CONDUCTED VIA RECTAL ACCESS, THIS TYPE OF INFECTION IS POSSIBLE. THIS IS A RISK INHERENT TO THIS TYPE OF PROCEDURE.