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

Catalog Number 8005P10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 03/12/2014

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.This mdr is related to 2135225-2015-00091 & 2135225-2015-00093.

Event Description

The patient was enrolled in the coaptite injectable implant study for stress urinary incontinence.On (b)(6) 2012 the patient was injected with 3.0ml of coaptite, lots 1032138 & 1031015.No adverse event reported.On (b)(6) 2012 the patient was injected with 4.0ml of coaptite, lots 1034173, 1032763, 1032765.On (b)(6) 2014 the patient reported a urinary tract infection.On (b)(6) 2014 the patient was prescribed antibiotic treatment by her primary care physician (name of antibiotic, dose & duration unknown).The physician assessed the event as mild and definitely 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, NC 27615 ; 9195828000
• MDR Report Key: 5190453
• MDR Text Key: 29927114
• Report Number: 2135225-2015-00094
• 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: 09/29/2015

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: 05/31/2015
• Device Catalogue Number: 8005P10
• Device Lot Number: 1032765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/07/2012
• 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: 72 YR
• Patient Weight: 79