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 05/27/2014

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.Device not returned to the manufacturer.

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 2.0ml of coaptite, lot 1033386.On (b)(6) 2014 the patient had a urinary tract infection that was diagnosed by emr md assessment.On (b)(6) 2014 the patient was treated with cipro 500mg bid x 5 days.As of (b)(6) 2014 the event was resolved.The physician assessed the event as mild 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, NC 27615 ; 9195828000
• MDR Report Key: 5189251
• MDR Text Key: 29925217
• Report Number: 2135225-2015-00089
• 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: 06/30/2015
• Device Catalogue Number: 8005P10
• Device Lot Number: 1033386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2012
• 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: 68 YR
• Patient Weight: 88