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

Catalog Number 8005P10

Device Problem Insufficient Information (3190)

Patient Problems Urinary Tract Infection (2120); Test Result (2695)

Event Date 11/23/2011

Event Type  Other  

Event Description

A pt (b)(6) was enrolled in (b)(6) study for stress urinary incontinence.On (b)(6) 2010, the pt was injected with 2.0 ml coaptite, lot 1018370.On (b)(6) 2012, the pt developed urinary tract infection identified through urinalysis.On (b)(6) 2012, the pt was treated with antibiotic ciprofloxacin 250mg po bid.The adverse event resolved on (b)(6) 2013.Per physician, the event was of mild severity and probably not related to coaptite.On (b)(6) 2013, the pt developed urinary tract infection reported by a pt.On (b)(6) 2013, the pt was treated with an antibiotic macrobid 100 mg po q12hrs x 10m days.The adverse event resolved on (b)(6) 2013.Per physician, the event was of mild severity and probably not related to coaptite.

Manufacturer Narrative

At the time of this report, the urinary tract infections have resolved.The device history records for the reported lots were reviewed, all required testing specs were met prior to release, there were no abnormalities noted.

Manufacturer Narrative

The device history records for the reported lot were reviewed.All required testing specifications were met prior to release.There were no abnormalities noted.

Event Description

The patient was enrolled in the coaptite injectable implant study for stress urinary incontinence.On (b)(6) 2013 the patient was injected with 2.0 ml of copatite, lot 1035202.On (b)(6) 2011 the patient had a urinary tract infection that was diagnosed by a urinalysis.On (b)(6) 2011 the patient was prescribed keflex 250mg tid x 7 days.As of (b)(6) 2011 the event was resolved.The physician assessed the event as mild and possibly device related.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MEZ NORTH AMERICA, INC.; franksville WI
• Manufacturer Contact: r. stemler ; 4133 courtney road, ste #10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4223987
• MDR Text Key: 5068866
• Report Number: 2135225-2014-00073
• 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,company representati
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 8005P10
• Device Lot Number: 1035202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2012
• 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: 78 YR
• Patient Weight: 70