FDA Adverse Event Other Summary report: N

COAPTITE INJECTABLE IMPLANT

MDR report key: 3429656 · Received October 17, 2013

Report

Report Number: 2135225-2013-00129
Event Type: Other
Date Received: October 17, 2013
Date of Event: April 4, 2014
Report Date: September 29, 2015
Manufacturer: MERZ NORTH AMERICA, INC
Product Code: LNM
PMA / PMN Number: P040047
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

AT THE TIME OF THIS REPORT THE URINARY RETENTION HAD RESOLVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOT #1032138 MET ALL SPECS PRIOR TO RELEASE WITH 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 WAS INJECTED WITH 2.0 ML OF COAPTITE LOT #1032138 (X2) ON (B)(6) 2012. THE PT REPORTED URINARY RETENTION FOLLOWING THE PROCEDURE ON (B)(6) 2012 AND WAS TREATED WITH FOLEY CATHETERIZATION. THE RETENTION RESOLVED ON (B)(6) 2012. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENT AS MILD AND DEFINITELY DEVICE-RELATED.

Description of Event or Problem · 1

THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY FOR STRESS URINARY INCONTINENCE. ON (B)(6) 2014 THE PATIENT REPORTED A URINARY TRACT INFECTION. ON (B)(6) 2014 THE PATIENT WAS PRESCRIBED CIPRO 500MG PO BID X 10 DAYS. AS OF (B)(6) 2014 THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS MODERATE AND DEFINITELY NOT DEVICE RELATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
532346	COAPTITE INJECTABLE IMPLANT	INJECTABLE IMPLANT	LNM	MERZ NORTH AMERICA, INC		1032138

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention