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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GALDERMA Q-MED AB DEFLUX; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
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GALDERMA Q-MED AB DEFLUX; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Manufacturer comment: lot number was not reported.Pharmacovigilance comment: the serious event of implant site calcification and the non-serious events of abnormal urine and urethral pain were considered expected and possibly related to the treatment.The manufacturer upgraded the case to serious status and serious criteria include the need for surgical intervention to remove the calcified lesion.The case meets the criteria for expedited reporting to the regulatory authorities.Capa: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.
 
Event Description
Case reference number (b)(4) is a literature report obtained on 27-apr-2020 in a literature screening.Article reference: santiapillai j, symes a.; a rare and unusual complication of the sting procedure.; urol case rep.2020 apr 2;32:101174.Doi: 10.1016/j.Eucr.2020.101174.Ecollection 2020 sep.The authors concluded that (indicate the conclusions).We describe a case of a (b)(6)-year-old boy who presented to the paediatric team with the passage of sediment in his urine every 7 weeks, associated with recurrent penile and urethral pain.Aged (b)(6) years-old, he was investigated for recurrent utis and found to have right sided grade-4 vur.This was treated with a sting procedure using dextranomer/hyaluronic acid copolymer (deflux).At (b)(6) years-old, he started passing sediment per urethra and presented to the paediatric surgery team.Investigations including blood tests and urine were normal.Ultrasound scan (uss) showed normal kidneys and an echobright round focus at the level of the right vescioureteric junction (vuj).This was felt to be a likely sequela of previous sting procedure.As his symptoms spontaneously resolved, no interventions were undertaken.He subsequently presented to adult urology two years later aged (b)(6), with recurrence of his symptoms.Again every 7 weeks, he passed grit and debris per urethra, with recurrent episodes of penile and urethral pain, in the absence of any uti.A sample of the debris, sent for analysis, was inconclusive and no stone demonstrated.Uss again demonstrated a bright area at the vuj.Differential diagnosis included a stone in a ureterocoele or complication from previous anti-reflux procedure.A ct scan demonstrated a calcified lesion at the right vuj.Uroradiology review excluded stone disease or ureterocoele, with calcification thought to be related to previous sting procedure.Given the patient's ongoing symptoms a decision was made to perform cystoscopy under general anaesthetic and possible resection of the area.Cystoscopy revealed a 2cm suburothelial mass adjacent to the right vuj, with normal urothelium overlying it.The ureteric orifice was seen and appeared uninvolved.Resection of the area revealed a white plasticlike substance, consistent with the bulking agent deflux, which was scraped away leaving a small cavity.The patient made an uneventful recovery and at review, 3 months later, is symptom free.
 
Manufacturer Narrative
Manufacturer comment: lot number was not reported.Pharmacovigilance comment: the serious event of implant site calcification and the non-serious events of abnormal urine and urethral pain were considered expected and possibly related to the treatment.The manufacturer upgraded the case to serious status and serious criteria include the need for surgical intervention to remove the calcified lesion.The case meets the criteria for expedited reporting to the regulatory authorities.Capa: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.(b)(4).
 
Event Description
Case reference number (b)(4) is a literature report obtained on 27-apr-2020 in a literature screening.Article reference: santiapillai j, symes a.; a rare and unusual complication of the sting procedure.; urol case rep.2020 apr 2;32:101174.Doi: 10.1016/j.Eucr.2020.101174.Ecollection 2020 sep.The authors concluded that (indicate the conclusions).We describe a case of a 17-year-old boy who presented to the paediatric team with the passage of sediment in his urine every 7 weeks, associated with recurrent penile and urethral pain.Aged 8 years-old, he was investigated for recurrent utis and found to have right sided grade-4 vur.This was treated with a sting procedure using dextranomer/hyaluronic acid copolymer (deflux).At 17 years-old, he started passing sediment per urethra and presented to the paediatric surgery team.Investigations including blood tests and urine were normal.Ultrasound scan (uss) showed normal kidneys and an echobright round focus at the level of the right vescioureteric junction (vuj).This was felt to be a likely sequela of previous sting procedure.As his symptoms spontaneously resolved, no interventions were undertaken.He subsequently presented to adult urology two years later aged 19, with recurrence of his symptoms.Again every 7 weeks, he passed grit and debris per urethra, with recurrent episodes of penile and urethral pain, in the absence of any uti.A sample of the debris, sent for analysis, was inconclusive and no stone demonstrated.Uss again demonstrated a bright area at the vuj.Differential diagnosis included a stone in a ureterocoele or complication from previous anti-reflux procedure.A ct scan demonstrated a calcified lesion at the right vuj.Uroradiology review excluded stone disease or ureterocoele, with calcification thought to be related to previous sting procedure.Given the patient's ongoing symptoms a decision was made to perform cystoscopy under general anaesthetic and possible resection of the area.Cystoscopy revealed a 2cm suburothelial mass adjacent to the right vuj, with normal urothelium overlying it.The ureteric orifice was seen and appeared uninvolved.Resection of the area revealed a white plasticlike substance, consistent with the bulking agent deflux, which was scraped away leaving a small cavity.The patient made an uneventful recovery and at review, 3 months later, is symptom free.
 
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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
MDR Report Key10088673
MDR Text Key194875077
Report Number9710154-2020-00045
Device Sequence Number1
Product Code LNM
Combination Product (y/n)N
PMA/PMN Number
P000029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Type of Report Initial,Followup
Report Date 05/26/2020
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/27/2020
Initial Date FDA Received05/26/2020
Supplement Dates Manufacturer Received04/27/2020
Supplement Dates FDA Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age17 YR
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