FDA Adverse Event Other Summary report: N

COAPTITE INJECTABLE IMPLANT

MDR report key: 2334463 · Received November 4, 2011

Report

Report Number: 2135225-2011-00147
Event Type: Other
Date Received: November 4, 2011
Date of Event: April 17, 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: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADD'L LOTS USED: 8005P10 - 1013660, EXP 06/2012; AND 8005P10 - 1015082, EXP 09/2012. THE DEVICE HISTORY RECORDS FOR LOT 1013660, 1015082 AND 1015604 WERE REVIEWED, ALL REQUIRED TESTING SPECS WERE MET PRIOR TO RELEASE, THERE WERE NO ABNORMALITIES NOTED.

Description of Event or Problem · 1

A PT (B)(6), WAS ENROLLED IN THE POST-APPROVAL COAPTITE INJECTABLE IMPLANT STUDY FOR STRESS URINARY INCONTINENCE. THE PT WAS INJECTED WITH 1.0 ML COAPTITE (LOT 1013660) ON (B)(6) 2009; WITH 1.0 ML COAPTITE (LOT 1015082) ON (B)(6) 2009 AND WITH 2.0 ML COAPTITE (LOT 1015604 X 2) ON (B)(6) 2010. THE PT FIRST EXPERIENCED A CLOT RETENTION OF URINE THAT STARTED ON (B)(6) 2009 AND RESOLVED ON THE SAME DAY. THE TREATMENT WAS BLADDER IRRIGATION. PER PHYSICIAN, THE EVENT WAS OF MODERATE SEVERITY AND PROBABLY NOT RELATED TO COAPTITE. ON (B)(6) 2010, THE PT EXPERIENCED HEMORRHAGE. THE PT WAS ON COUMADIN, SHE WAS DISCHARGED IN STABLE CONDITION WITHOUT EVIDENCE OF BLEEDING. APPARENTLY THE PT WAS ACTIVE WHEN SHE GOT HOME AND STARTED BLEEDING. ON (B)(6) 2010, THE PT RECEIVED 2 UNITS OF BLOOD TRANSFUSION AND RECOVERED ON (B)(6) 2010. PER PHYSICIAN, THE EVENT WAS OF MODERATE SEVERITY AND PROBABLY NOT RELATED TO COAPTITE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COAPTITE INJECTABLE IMPLANT	INJECTABLE IMPLANT	LNM	MERZ AESTHETICS, INC		1015604

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Required Intervention