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 06/23/2014

Event Type  Other  

Event Description

A pt, (b)(6) was enrolled in (b)(6) study for stress urinary incontinence.The pt was injected with 1.7 ml of coaptite from lots # 1028864 and 1029563 on (b)(6) 2012.The pt was injected with 2.7ml of coaptite from lots 1032138 and 1028864 on (b)(6) 2012.On (b)(6) 2012, the pt reported urge incontinence that was treated with enablex on (b)(6) 2012.The physician assessed the event as moderate in severity and definitely not device related.On (b)(6) 2013, the pt reported a urinary tract infection and a urinalysis was performed.On (b)(6) 2013, the pt was prescribed bactrim ds po qd.The infection was resolved by (b)(6) 2013.The physician assessed the event as moderate in severity and definitely not device related.On (b)(6) 2013, the pt reported a urinary tract infection and a urinalysis was performed.On (b)(6) 2013, the pt was prescribed bactrim ds po bid.The infection was resolved by (b)(6) 2013.The physician assessed the event as moderate in severity and definitely not device related.On (b)(6) 2013 the pt reported a urinary tract infection and a urinalysis was performed.On 05/07/2013 the pt was prescribed bactrim ds po qd.The infection was resolved by (b)(6) 2013.The physician assessed the event as moderate in severity and definitely not device related.On (b)(6) 2013, a urinalysis was performed and a urinary tract infection was diagnosed.On (b)(6) 2013, the pt was prescribed bactrim ds po bid.The infection was resolved by (b)(6) 2013.

Manufacturer Narrative

Add'l cat # 8005p10, 8005p10, lot #1029563, 1032138.Exp.Date: 12/2014, 04/2015, mfr date: 04/2012, implant date: (b)(6) 2012.The physician assessed the event as moderate in severity and definitely not device related.At the time this report was received, the pt's urinary tract infections had resolved.The device history records for the reported lots were reviewed.All required testing specs were met prior to release with no abnormalities noted.

Event Description

The patient was enrolled in the (b)(4) study for stress urinary incontinence.On (b)(6) 2014 the patient reported a urinary tract infection.On (b)(6) 2015 the patient was prescribed cipro 500mg po bid x 5 days.As of 06/24/2014 the event was resolved.The physician assessed the case as moderate and definitely not device related.On (b)(6) 2014 the patient reported a urinary tract infection.On (b)(6) 2014 the patient was prescribed cipro 500mg po bid x 5 days.The physician assessed the case as mild and definitely not device related.On (b)(6) 2015 the patient reported a urinary tract infection.On (b)(6) 2015 the patient was prescribed cipro 500mg po bid x 5 days.As of 05/04/2015 the event was resolved.The physician assessed the case as mild and definitely not device related.

• 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, #10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4223985
• MDR Text Key: 5068865
• Report Number: 2135225-2014-00085
• 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,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2015

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: 10/01/2014
• Device Catalogue Number: 8005P10
• Device Lot Number: 1028864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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: 60 YR
• Patient Weight: 75