COAPTITE

Report

Report Number: 2135225-2011-00142
Event Type: Other
Date Received: November 4, 2011
Date of Event: September 17, 2009
Report Date: October 7, 2011
Manufacturer: MERZ AESTHETICS, INC
Product Code: LNM
PMA / PMN Number: P040047
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT WAS REPORTED IN THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR PMA P040047, (B)(6) 2011. ADD'L LOT NUMBER OF COAPTITE INJECTED INTO THE PT: 1012641 DATE INJECTED: (B)(6) 2009; LOT 1012641 WAS REPORTED BUT IS NOT A VALID LOT NUMBER FOR COAPTITE; 1012956 EXP DATE: 03/2012 MFR DATE: 03/2009 DATE INJECTED: (B)(6) 2009. THE PHYSICIAN DETERMINED THAT THE URINARY RETENTION WAS MODERATE AND WAS DEFINITELY RELATED TO THE COAPTITE. THE PHYSICIAN DETERMINED THAT THE UTI WAS MODERATE AND WAS POSSIBLY RELATED TO THE COAPTITE. THE DEVICE HISTORY RECORDS FOR LOT NUMBERS 1012834 AND 1012956 WERE REVIEWED; ALL REQUIRED TESTING SPECS HAD BEEN MET PRIOR TO RELEASE, AND THERE WERE NO ABNORMALITIES NOTED.

Description of Event or Problem · 1

A PT (B)(6) WAS ENROLLED IN THE COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PT HAS HAD ONE PREVIOUS COAPTITE TREATMENT (DATE OF PREVIOUS TREATMENT NOT PROVIDED). ON (B)(6) 2009, THE PT WAS INJECTED WITH 3.0ML OF COAPTITE (LOTS 1012834, 1012641 & 1012956). ON (B)(6) 2009, THE PT REPORTED URINARY RETENTION. A FOLEY CATHETER WAS PLACED AND THE URINARY RETENTION WAS RESOLVED BY (B)(6) 2009. ON (B)(6) 2009, THE PT WAS DIAGNOSED WITH A URINARY TRACT INFECTION (UTI) AFTER A URINALYSIS. THE PT WAS PLACED ON AN ANTIBIOTIC THERAPY (DRUG NAME, DOSE & DURATION NOT PROVIDED). ON (B)(6) 2009 THE UTI WAS RESOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COAPTITE	INJECTABLE IMPLANT	LNM	MERZ AESTHETICS, INC		1012934

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR		Required Intervention