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

Catalog Number 8005P10

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Incontinence (1928); Swelling (2091); Therapeutic Response, Decreased (2271)

Event Date 10/17/2012

Event Type  Other  

Event Description

A pt, (b)(6) was enrolled to the coaptite injectable implant study for stress urinary incontinence.The pt was injected with 1.0 ml of coaptite lot #1034459 on (b)(6) 2012.The pt reported swelling on (b)(6) 2012 which was reported due to the coaptite injection.The pt went to the er and was treated with foley catheterization.The swelling resolved on (b)(6) 2012.The physician assessed the event as mild in severity and definitely device related.On (b)(6) 2012 the pt reported urge incontinence.On (b)(6) 2012, the pt was treated with anticholinergic topical gelnique.Resolution date was not reported.The physician assessed the event as mild in severity and definitely not device related.

Manufacturer Narrative

At the time of this report was received, the pt's swelling had resolved.The device history records for the reported was reviewed.All required testing specs 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, #10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4223972
• MDR Text Key: 5070750
• Report Number: 2135225-2014-00078
• 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

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Catalogue Number: 8005P10
• Device Lot Number: 1034459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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: 73 YR
• Patient Weight: 68