MAUDE Adverse Event Report: CONTURA INTERNATIONAL A/S BULKAMID(R) URETHRAL BULKING SYSTEM

Model Number 50012

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Sepsis (2067); Urinary Tract Infection (2120)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

Contura concludes that urosepsis is related to the uti.The patient had a positive urine stix prior to the procedure.Uti is contraindicated according to the ifu.The uti may possibly be related to the bulking procedure as uti is a known complication of cystoscopy procedures.The bulkamid instruction for use (ifu) includes a warning about using the product in case of an active infection.Furthermore the ifu informs that uti can be a possible complication after the procedure and treatment with antibiotics prior to the procedure is mandated.This patient has a prior history of uti with complications and was not given antibiotics prior to the procedure.

Event Description

Patient received treatment with bulkamid on friday (b)(6) 2020.On (b)(6) 2020 the patient presented with urosepsis and septic shock, hematuria and low blood pressure.Patient was admitted and received iv antibiotics, phenyephrine and 3-way bladder irrigation.Ct scan showed no kidney damage.Treatment took 48 hrs.

• Brand Name: BULKAMID(R) URETHRAL BULKING SYSTEM
• Type of Device: BULKAMID
• Manufacturer (Section D): CONTURA INTERNATIONAL A/S; sydmarken 23; soeborg, copenhagen 2860 ; DA 2860
• Manufacturer (Section G): CONTURA INTERNATIONAL A/S; sydmarken 23; soeborg, copenhagen 2860 ; DA 2860
• Manufacturer Contact: carina moldow ; sydmarken 23; soeborg, copenhagen 2860 ; DA 2860
• MDR Report Key: 10843109
• MDR Text Key: 216358701
• Report Number: 3005111102-2020-00001
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 50012
• Device Lot Number: 19F0301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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: PHARMACOLOGICAL TREATMENT FOR OVERACTIVE BLADDER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR