COAPTITE INJECTABLE IMPLANT

Report

Report Number: 2135225-2013-00122
Event Type: Other
Date Received: October 17, 2013
Date of Event: August 23, 2013
Report Date: September 20, 2013
Manufacturer: MERZ NORTH AMERICA, INC.
Product Code: LNM
PMA / PMN Number: P040047
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AT THE TIME OF THIS REPORT THE URINARY RETENTION HAD RESOLVED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOTS WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS WERE MET PRIOR TO RELEASE. THERE WERE NO ABNORMALITIES. ADDITIONAL DEVICE INFO: LOT: 1016313, EXP DATE: 11/2012. MANUFACTURER DATE FOR LOT 1016313 IS 11/2009.

Description of Event or Problem · 1

A PT ((B)(6)) WAS ENROLLED IN (B)(4). ON (B)(6) 2010 THE PT WAS INJECTED WITH 2.0 ML OF COAPTITE, LOT 1012274, (B)(4). ON (B)(6) 2010 THE PT WAS INJECTED WITH 4.0 ML OF COAPTITE, LOT 1016313. ON (B)(6) 2010 THE DOCTOR PERFORMED A PERIURETHRAL EXAM AND DIAGNOSED HEMATURIA THAT WAS TREATED WITH IRRIGATION AND VITAMIN K. THIS WAS RESOLVED BY (B)(6) 2010. ON (B)(6) 2010 A UA WAS PERFORMED AND THE PT WAS DIAGNOSED WITH URINARY RETENTION, ON (B)(6) 2010 A STRAIGHT CATHETER WAS PLACED. THE PT WAS INSTRUCTED TO INSERT CATHETER INTO THE BLADDER WHEN SHE FELT LIKE SHE DID NOT EMPTY THE BLADDER GOOD. PER THE PHYSICIAN, THIS WAS OF MODERATE SEVERITY AND DEFINITELY NOT RELATED TO THE COAPTITE. ON (B)(6) 2012 THE PT REPORTED HEMATURIA THAT WAS NOT TREATED. THE PT STATED THAT IT ONLY LASTED 24 HRS. ON (B)(6) 2012 THE PT REPORTED ABDOMINAL PAIN THAT WAS NOT TREATED. THE PT STATED THAT IT ONLY LASTED 24 HRS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
532355	COAPTITE INJECTABLE IMPLANT	INJECTABLE IMPLANT	LNM	MERZ NORTH AMERICA, INC.		1012274, 1012833

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention