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

Lot Number UNKNOWN

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

Patient Problems Obstruction/Occlusion (2422); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comments: the serious events of ureteric obstruction and hydronephrosis were considered expected and possibly related to the treatment.Serious criteria include the need for surgical intervention to prevent permanent damage.The likely root cause for ureteric obstruction includes product characteristics since the tissue bulking around the dextranomer microspheres is the mechanism of action to prevent retrograde urine flow; too much bulking can lead to ureteral obstruction and hydronephrosis.The case meets the criteria for expedited reporting to the regulatory authorities.Engineering evaluation: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.Manufacturer narrative: routine investigations have been performed and provide sufficient information to assess the potential root cause.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.

Event Description

Case reference number (b)(4) is a spontaneous,literature report obtained on (b)(6) 2021.A (b)(6) year-old girl presented us with a recurrent febrile urinary tract infection.Ultrasound demonstrated no hydronephrosis and bladder wall appeared smooth.Dimercaptosuccinic acid (dmsa) renal scan revealed bilateral renal scarring.Voiding cystourethrogram (vcug) showed grade 2 on the right and grade 3 on the left vur.Although she had sometimes experienced night incontinence, obvious bladder dysfunction was not detected.A bilateral combined hydrodistensionimplantation technique (hit)/subureteral tansurethral injection (sting) procedure was performed using of 0.7ml of dx/ha on the right side and 1.0ml on the left side.On initial postoperative ultrasound at 2 weeks later, hydronephrosis was not detected in both kidney.At seven months, ultrasound imaging revealed an asymptomatic bilateral de novo hydronephrosis.At ten month postoperatively, findings had deteriorated with bilateral hydroureteronephrosis.Significant distal ureteral dilation were seen on transverse images of bladder.Mercaptoacetyltriglycine (mag3) diuretic renal scan showed delayed washout on both kidney.Ct scan demonstrated bilateral hydroureteronephrosis and fluid collection on bilateral ureterovesical junction.The child underwent an open bilateral reimplantation immediately after ct examination.Intraoperatively, a 14 mm nodule on the right and a 16 mm on the left located periureteral orifice were observed.When a small incision was made on nodules, a yellowish-white mucinous fluid flowed out from both sides.The dx/ha material was irrigated with saline, and complete evacuation of the cavity was achieved.Macroscopically, the fluid replaced the usual appearance of the dx/ha.The distal ureters were excised and a cohen cross-trigonal ureteral reimplantation was performed.Follow-up ultrasound at fifty days postoperatively showed a resolution of hydronephrosis.The examination of dx/ha material culture was negative.Pathological analysis revealed giant cell reaction in setting of acute and chronic inflammation encapsulating dextranomer microspheres and it was located in the serosa.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): GALDERMA Q-MED AB; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 14501 n. freeway; fort worth, TX 76177
• MDR Report Key: 11251688
• MDR Text Key: 233284515
• Report Number: 9710154-2021-00006
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2021

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: 01/04/2021
• Initial Date FDA Received: 01/29/2021
• 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): Required Intervention
• Patient Age: 4 YR