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 Problems Incontinence (1928); Therapeutic Response, Decreased (2271); Test Result (2695)

Event Date 04/12/2012

Event Type  Other  

Event Description

A pt (b)(6) was enrolled in the (b)(4) study for stress urinary incontinence.On (b)(6) 2012, the pt was injected with 1.0 ml coaptite, lot 1027423; and on (b)(6) 2012, the pt was injected with 1.0 ml coaptite, lot 1028864.Additionally, on (b)(6) 2014, the pt was injected with 2.0 ml coaptite, lot 1031016.On (b)(6) 2012, the pt developed urinary retention diagnosed by a bladder ultrasound.The pt was treated with foley catheterization and recovered by (b)(6) 2012.Per physician, the event was of mild severity and definitely related to coaptite.On (b)(6) 2012, the pt developed urge incontinence as reported by pt.The pt was treated on (b)(6) 2012 with vesicare x 2 weeks and gelnique topical x 2 weeks and recovered by (b)(6) 2012.Per physician, the event was of mild severity and definitely not related to coaptite.

Manufacturer Narrative

Add'l lot injected on 04/12/2012; 1028864.(expiration date 10/2014, manufactured 10/2011).Add'l lot injected on 05/16/2012: 1031016.(expiration date 02/2015, manufactured 02/2012).The device history records for the three 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: 4223983
• MDR Text Key: 18094380
• Report Number: 2135225-2014-00071
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 88