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 03/21/2013

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 the mdr 2135225-2015-00079.

Event Description

A patient ((b)(6)) was enrolled in the post-approval coaptite injectable implant study for stress urinary incontinence.The patient was injected with a total of 3.0ml of coaptite, lots 1033386, 1032766, 1032765 on (b)(6) 2012.On (b)(6) 2013 a urine culture was performed and the patient was diagnosed with a urinary tract infection.The patient was treated with keflex 500mg bid x 7 days starting on (b)(6) 2013.As of (b)(6) 2013 the event was resolved.The physician assessed the event as mild and possibly 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: 5176652
• MDR Text Key: 29215039
• Report Number: 2135225-2015-00082
• 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

• Date FDA Received: 10/25/2015
• 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
• Date Manufacturer Received: 09/25/2015
• 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: 85 YR
• Patient Weight: 73