FDA Adverse Event Injury Summary report: N

INTERMITTENT MAGIC3

MDR report key: 5010203 · Received August 14, 2015

Report

Report Number: 1018233-2015-00289
Event Type: Injury
Date Received: August 14, 2015
Date of Event: February 9, 2015
Report Date: July 23, 2015
Manufacturer: ROCHESTER MEDICAL CORP.
Product Code: KOD
PMA / PMN Number: K000723
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR EVAL. THE LOT NUMBER IS UNK THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "HOW TO PREPARE AND USE THE MAGIC 3 CATHETER. THE CATHETER IS INTENDED FOR URINARY BLADDER DRAINAGE IN PTS REQUIRING CATHETERIZATION FOR MANAGEMENT OF INCONTINENCE, VOIDING DYSFUNCTION, AND SURGICAL PROCEDURES. THIS IS A SINGLE USE DEVICE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. URETHRAL CATHETER FOR UROLOGICAL USE ONLY. DISCARD AFTER USE, DO NOT RESTERILIZE. MADE OF SILICONE ELASTOMER". (B)(4). THE INFO PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFO AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFO, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PT, PRODUCT OR PROCEDURAL DETAILS TO BARD.

Description of Event or Problem · 1

IT WAS REPORTED THAT ON (B)(6) 2015 THE PT EXPERIENCED A URINARY TRACT INFECTION AND BURNING WHILE URINATING AS A RESULT OF USING THE DEVICE. THE PT WAS PRESCRIBED AMOXICILLIN AND CEFDINIR TO TREAT THE INFECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
539978	INTERMITTENT MAGIC3		KOD	ROCHESTER MEDICAL CORP.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention