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 10/17/2012

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 1.5 ml of coaptite lot 31012957 (2) on (b)(6) 2009 without issue.The pt was injected a second time on (b)(6) 2009 with 2.0 ml of lot #1010448 and 1.0 ml of lot #1010803.The pt developed a urinary tract infection diagnosed by urinalysis on (b)(6) 2010.The pt was treated with macrobid starting (b)(6) 2010.The infection resolved on (b)(6) 2010.The physician assessed the event as mild in severity and probably no device related.

Manufacturer Narrative

Additional lots used for injection on (b)(6) 2009: #1010488 (exp 07/2011, mfr date 07/2008), #1010803 (exp 10/2011, mfr date 10/2008).Implant date: (b)(6) 2009.At the time of this report, the pt's uti had resolved.The device history records for the 3 reported lots were reviewed.All required testing specifications were met prior to release with no abnormalities noted.

• 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: 4223990
• MDR Text Key: 5068867
• Report Number: 2135225-2014-00079
• 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: 03/01/2012
• Device Catalogue Number: 8005P10
• Device Lot Number: 1012957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/29/2014
• Date Device Manufactured: 03/01/2009
• 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: 88 YR
• Patient Weight: 73