MAUDE Adverse Event Report: Q-MED DEFLUX; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Calcium Deposits/Calcification (1758)

Event Type  Injury  

Event Description

This spontaneous report (b)(4) was received on (b)(6) 2022 from a physician concerning a female patient of an unknown age (reported to be a child).No information about medical history, concomitant medication, history of allergies or previous similar treatments have been reported.On an unknown date, the patient received treatment with deflux to ureter.The volume used, lot number, needle type and injection technique were unknown.The reporting physician responded to the child's mother on social media regarding long term calcification/calcification of deflux bleb misdiagnosis as ureteral stone (implant site calcification).The child's mother posted that she would not have her child undergo deflux treatment again as she was diagnosed with a "stone" and had complications from ureteroscopy looking for stones.The reporting physician responded to the mother and she was very appreciative.Outcome at the time of the report: implant site calcification was unknown.

Manufacturer Narrative

Compant comment: the serious event of implant site calcification was considered expected and possibly related to the treatment.Seriousness criteria include other important medical event.Potential root cause include micro calcification of deflux implant, which is a known inflammatory and histologic reaction of deflux ureteral implantation.The case meets the criteria for expedited reporting to the regulatory authorities.Product notes: routine investigations have been performed and indicate a possible association to the treatment product.The lot number was not reported and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Recommendation for corrective and preventative action: deflux-no corrective or preventive actions are deemed necessary based on the performed investigations.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 14779730
• MDR Text Key: 295055078
• Report Number: 9710154-2022-00040
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2022

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/22/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female