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

Event Date 04/09/2012

Event Type  Injury  

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.This mdr is related to mdr 2135225-2015-00090.

Event Description

The patient was enrolled in the coaptite injectable implant study for stress urinary incontinence.On (b)(6) 2009 the patient was injected with 2.0ml of coaptite, lots 1011520 & 1010803.No adverse event reported.On (b)(6) 2009 the patient was injected with 3.0ml of coaptite, lot 1012109.On (b)(6) 2010 the patient had a urinary tract infection (diagnosed by urine c and s).On (b)(6) 2010 the patient was prescribed macrobid 100mg bid x 7 days, then 1 qhs #45.As of (b)(6) 2010 the event was resolved.The physician assessed the event as mild and probably not device related.On (b)(6) 2010 the patient was injected with 3.0ml of coaptite, lot 1015082.On (b)(6) 2012 the patient had a urinary tract infection that was diagnosed by a urinalysis.On (b)(6) 12 the patient was prescribed ciprofloxacin 400mg ivpb.The patient was admitted and ceftriaxone was administered by iv as well as rocephin iv.The patient was also given omnicef 300mgpo bid.The physician assessed the event as severe and probably not device related.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney rd; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 4133 courtney rd; franksville WI 53126
• Manufacturer Contact: ann metz ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 5189969
• MDR Text Key: 29924946
• Report Number: 2135225-2015-00092
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: Physician
• Device Expiration Date: 09/30/2012
• Device Catalogue Number: 8005P10
• Device Lot Number: 1015082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/08/2009
• 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: 82 YR
• Patient Weight: 84