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

Catalog Number 8005P10

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Date 04/22/2014

Event Type  Injury  

Manufacturer Narrative

The device history records for the reported lot were reviewed.All required testing specifications were met prior to release.There were no abnormalities noted.

Event Description

A patient ((b)(6)) was enrolled in the post-approval (b)(6) study for stress urinary incontinence.The patient was injected with a total of 3.0ml of coaptite, lot 100065918 on (b)(6) 2014.On (b)(6) 2014 the patient reported a urinary tract infection.The patient was treated with macrobid 100mg po bid x 5 days.The event resolved on (b)(6) 2014.The physician assessed the event as moderate and probably not device related.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney rd; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 4133 courtney rd; franksville WI 53126
• Manufacturer Contact: ann metz ; 6501 six forks rd; raleigh 27615 ; 9195828000
• MDR Report Key: 5175866
• MDR Text Key: 29214936
• Report Number: 2135225-2015-00077
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2015

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: Physician
• Device Expiration Date: 07/19/2016
• Device Catalogue Number: 8005P10
• Device Lot Number: 100065918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 10/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2013
• 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: 67 YR
• Patient Weight: 81