MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC COAPTITE INJECTABLE IMPLANT

Catalog Number 8005P10

Device Problem Insufficient Information (3190)

Patient Problems Urinary Tract Infection (2120); Test Result (2695)

Event Date 04/19/2013

Event Type  Other  

Event Description

A pt, (b)(6) was enrolled in the (b)(4) study for stress urinary incontinence.On (b)(6) 2011, the pt was injected with 2.0 ml coaptite, lot 1019799.On (b)(6) 2013, the pt developed urinary tract infection identified by urinalysis.On (b)(6) 2013, the pt was treated with antibiotic keflex 500 mg po 07 days and cefdinir 300 mg po 7 days.The adverse event resolved on (b)(6) 2013.Per physician, the event was of mile severity and probably not related to coaptite.On (b)(6) 2013, the pt developed urinary tract infection identified by urinalysis.On (b)(6) 2013 the pt was treated with antibiotic 300mg po bid x 10 days and foley catheterization.The adverse event resolved on (b)(6) 2013.Per physician, the event was of mild severity and probably not related to coaptite.

Manufacturer Narrative

At the time of this report, the urinary tract infections have resolved.The device history records for the reported lot were reviewed.All required testing specifications were met prior to release with no abnormalities noted.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA, INC; franksville WI
• Manufacturer Contact: r stemler ; 4133 courtney road, #10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4223989
• MDR Text Key: 19302023
• Report Number: 2135225-2014-00074
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2013
• Device Catalogue Number: 8005P10
• Device Lot Number: 1019799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/29/2014
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 64