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

Catalog Number 8005P10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Urinary Retention (2119)

Event Date 11/08/2012

Event Type  Other  

Event Description

A pt, ((b)(6)) was enrolled in the coaptite injectable implant study for stress urinary incontinence.The pt was injected with a total of 3.0 ml of coaptite on (b)(6) 2012; 1.0 ml of lot #1035200 and 2.0 ml of lot # 1034615 (2).On (b)(6) 2012 the pt reported urinary retention.The pt was treated with foley catheterization on (b)(6) 2012.The retention resolved on (b)(6) 2012.The physician assessed the event as moderate in severity and definitely device related.

Manufacturer Narrative

At the time this report was received the pt's urinary retention had resolved.The dhr for the 2 reported lots were reviewed.All required testing specifications were met prior to release with no abnormalities noted.Additional lot: 1034615.Additional expiration date: 08/01/2015.Additional device mfr date: 08/2012.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA, INC; franksville WI
• Manufacturer Contact: valerie drescher ; 4133 courtney road; ste 10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4223991
• MDR Text Key: 5071354
• Report Number: 2135225-2014-00080
• 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: 08/01/2015
• Device Catalogue Number: 8005P10
• Device Lot Number: 1035200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2012
• Initial Date FDA Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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
• Treatment: TOVIAZ, 4MG
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 75