COAPTITE

Report

Report Number: 2135225-2011-00138
Event Type: Other
Date Received: November 4, 2011
Date of Event: July 14, 2010
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: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS EVENT WAS REPORTED IN THE INTERIM POST-APPROVAL STUDY STATUS REPORT FOR PMA (B)(4), (B)(4) 2011. ADD'L LOT NUMBERS OF COAPTITE INJECTED INTO THE PT: 1014238 DATE INJECTED: (B)(6) 2009. THIS LOT NUMBER WAS NOT A VALID LOT NUMBER; 1015022 EXP DATE: 9/2012, MFR DATE: 9/2009 DATE INJECTED: (B)(6) 2010; 1014034 EXP DATE: 6/2012, MFR DATE: 7/2009, DATE INJECTED: (B)(6) 2010; 1015605 EXP DATE: 10/2012, MFR DATE: 10/2009, DATE INJECTED: (B)(6) 2010. THE PHYSICIAN DETERMINED THAT THE URINARY TRACT INFECTION WAS MILD AND WAS DEFINITELY NOT RELATED TO THE COAPTITE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBERS WAS 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 (B)(4) STUDY FOR STRESS URINARY INCONTINENCE. THE PT HAS NOT HAD ANY PREVIOUS COAPTITE TREATMENTS. ON (B)(6) 2009, THE PT WAS INJECTED WITH 2 ML OF COAPTITE (LOTS 1013660 AND 1014238). ON (B)(6) 2010, THE PT WAS INJECTED WITH 2 ML OF COAPTITE (LOTS 1015022 AND 1014034). ON (B)(6) 2010, THE PT WAS INJECTED WITH 1 ML OF COAPTITE (LOT 1015605). ON (B)(6) 2010, THE PT WAS DIAGNOSED WITH A URINARY TRACT INFECTION (UTI) AFTER A URINALYSIS. THE PT WAS PRESCRIBED BACTRIM OS B.I.D. FOR 5 DAYS. ON (B)(6) 2010, THE UTI WAS RESOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COAPTITE	INJECTABLE IMPLANT	LNM	MERZ AESTHETICS INC		1013660

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Required Intervention