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

Catalog Number 8005P10

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Swelling (2091); Test Result (2695)

Event Date 08/02/2012

Event Type  Other  

Event Description

A pt (b)(6) was enrolled in the (b)(6) study for stress urinary incontinence.On (b)(6) 2012, the pt was injected with 2.0 ml coaptite, lot 1032764.On the same day, the pt developed urethral swelling as a result of the coaptite injection, diagnosed by bladder ultrasound.The pt was treated with straight catheterization adn foley catheterization and recovered.Per physician, the event was of mild severity and definitely related to coaptite.On (b)(6) 2013, the pt was injected with 1.0 ml coaptite, lot 1036243.On (b)(6) 2012, the pt developed urinary tract infection diagnosed by urine culture.The pt was treated with an antibiotic treatment and recovered.Per physician, the event was of mild severity and definitely not related to coaptite.

Manufacturer Narrative

Add'l lot injected: 1036243, expiration date 10/2015, manufactured 10/2012.The device history records for the reported lots were reviewed, all required testing specs were met prior to release, there were no abnormalities noted.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; franksville WI
• Manufacturer Contact: j. socava ; 4133 courtney road, ste #10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4223984
• MDR Text Key: 21174432
• Report Number: 2135225-2014-00069
• 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: 05/01/2015
• Device Catalogue Number: 8005P10
• Device Lot Number: 1032764
• 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: 05/01/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 77