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

Catalog Number 8005P10

Device Problem Insufficient Information (3190)

Patient Problem Micturition Urgency (1871)

Event Date 12/20/2013

Event Type  Other  

Event Description

A pt, (b)(6) was enrolled in the (b)(4) study for stress urinary incontinence.The pt was injected with 2.0 ml of coaptite lot 31031982 on (b)(6) 2012.On (b)(6) 2013, the pt reported urinary urgency.On (b)(6) 2013, a straight catheterization was performed.The problem ws resolved by (b)(6) 2013.Other medical history: on (b)(6) 2012, the pt had idiopathic chronic eosinophilic pneumonia and was hospitalized until (b)(6) 2012.On (b)(6) 2012 an ekg, cxr (chest x-ray), and echocardiogram were done and meds were given including bronchodilators.On (b)(6) 2012, a ct of the chest was done.On (b)(6) 2012, a bronchoscopy was done.On (b)(6) 2012, prednisone was given.On (b)(6) 2013, cxr and labs were done.Singulair was started.On (b)(6) 2013, a cxr was done.On (b)(6) 2013, allergy testing was done.On (b)(6) 2013, celebrex was discontinued.On (b)(6) 2013, a cxr and pulmonary function test was done.

Manufacturer Narrative

On (b)(6) 2013, a ct of the chest was done.On (b)(6) 2013, a pulmonary function testing (pft) was done.On (b)(6) 2013, a cxr and pft were done.On (b)(6) 2013, zyrtec, flonase and albuterol were added.On (b)(6) 2013, a cxr and pft were done.On (b)(6) 2013, a cxr and pft were done.The event of idiopathic chronic eosinophilic pneumonia was assessed by the physician as mild in severity and definitely not device related.On (b)(6) 2013, the pt had intermittent actinic keratoses.A physical exam was done by a physician and the pt was treated with a double freeze/thaw cycle.On (b)(6) 2013, a liquid nitrogen therapy was done.Also on (b)(6) 2013, intermittent seborrheic keratoses were noted, but not treated.The physician assessed both keratoses as mild in severity and definitely not device related.On (b)(6) 2013, the pt had a right lower extremity rash and was seen by a dermatologist.The physician noted that it is likely pretibial pruritic papular dermatitis.Koh scraping was performed.Negative for hyphae.The physician prescribed triamcinolone 0.17 cream two times a day, apply topically.The physician assessed the event as mild in severity and definitely not device related.On (b)(6) 2013, the pt had intermittent (b)(6) and was seen by a dermatologist.On (b)(6) 2013, the pt was put on a 5 day course of acyclovir 400mg by mouth 3 times a day.The physician assessed the event as mild in severity 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: 4223997
• MDR Text Key: 19722288
• Report Number: 2135225-2014-00084
• 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: 04/01/2015
• Device Catalogue Number: 8005P10
• Device Lot Number: 1031982
• 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: 04/01/2012
• 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
• Treatment: DETROL LA 4MG
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 96