MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. DURASPHERE INJECTABLE BULKING AGENT

Catalog Number 030966

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Abscess (1690)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Durasphere exp injectable bulking agent is a sterile, nonpyrogenic, single patient use device that is injected sub-mucosally at the bladder neck in the treatment of adult women with stress urinary incontinence due to intrinsic sphincteric deficiency.The potential for development of a delayed onset abscess at the site of injection is a known, inherent risk with this type of procedure and is documented within the device labeling.The device was not returned for evaluation.Biocompatibility testing has been conducted and has determined that the device is non-immunogenic.The device history record was not reviewed because lot identification information could not be obtained.Appropriate controls are in place to ensure that no discrepancies exist before release, including packaging and sterilization records.

Event Description

Patient developed a delayed onset abscess at site of injection (intravaginal) approximately 3 years post-injection.

• Brand Name: DURASPHERE INJECTABLE BULKING AGENT
• Type of Device: INJECTABLE BULKING AGENT
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road; saint paul MN 55110 5876
• Manufacturer (Section G): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road; saint paul MN 55110 5876
• Manufacturer Contact: andrew adams ; 1290 hammond road; saint paul, MN 55110-5876 ; 6516538512
• MDR Report Key: 7230701
• MDR Text Key: 98669719
• Report Number: 2134494-2017-00002
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P980053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2018

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: No Information
• Device Catalogue Number: 030966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other