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

Catalog Number 8005P10

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Date 02/12/2012

Event Type  Other  

Event Description

A pt, iw ((b)(6)) was enrolled in the coaptite injectable implant study for stress urinary incontinence.The pt was injected with 1.0 ml of coaptite lot #1027423 on (b)(6) 2012.The pt reported a urinary tract infection on (b)(6) 2012.The pt was treated with antibiotic, cipro x 10 days starting (b)(6) 2012.The infection resolved on (b)(6) 2012.The physician assessed the event as mild in severity and definitely not device related.

Manufacturer Narrative

(b)(4).At the time of report was received, the pt's urinary tract infection had resolved.The device history records for the reported lot was reviewed.All required testing specs were met prior to release with no anomalies noted.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA. INC.; franksville WI
• Manufacturer Contact: ann metz ; 4133 courtney road, ste #10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4223995
• MDR Text Key: 5068354
• Report Number: 2135225-2014-00083
• 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: 08/01/2014
• Device Catalogue Number: 8005P10
• Device Lot Number: 1027423
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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: OXYBUTININ 10MG; SANCTRA XR 60MG
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 59