MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.
[145648824]
Macroplastique implants are not indicated for treatment of vur within the united states (only female sui), however the vur indication exists for all geographies outside of the us. This event is being conservatively reported to fda as a) it was unclear based on the content of the published case study whether or not the macroplastique was removed at the time of bladder stone removal and b) due to the fact that treatment with mpq for vur is similar to that for sui and therefore this type of event has the potential to occur within the us.
Patient Sequence No: 1, Text Type: N, H10
[145648825]
This event was discovered during a literature search related to macroplastique for vesicoureteral reflux (vur) and is in the form of a case study. A (b)(6) female patient had undergone subureteral administration of mpq to treat bilateral vur when she was (b)(6). The patient presented with right flank pain, nausea and fever and had recurrent lower urinary tract symptoms, including dysuria, frequency and urgency for 6 months previous, which were partially relieved from empirical antibiotics for 3 days. Ultrasonography revealed a moderate degree hydronephrosis on the right kidney and two bladder stones (2. 0 cm and 1. 3 cm) near the right trigonal area of the bladder. A follow up urinalysis was performed which showed that the patient's symptoms and pyuria had resolved in seven days. The patient was diagnosed with distal ureteral obstruction induced by bladder sone and a cystolitholapaxy and right retrograde pyelography (rgp) were performed. Cystoscopy showed two yellowish impacted stones attached to the previous site of mpq administration, just below the right ureteral orifice. The stones were completely removed using cystolitholapaxy, however it is unclear whether or not the macroplastique was also removed at this time. Rgp was performed to evaluate other potential causes of ureteral obstruction and showed that the hydronephrosis was caused by the presence of bladder stones and not vur. The patient was monitored every three months for a 12 month post-operative period and had no abnormal finding or lower urinary tract symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2019-00001 |
| MDR Report Key | 8548984 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-19 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-04-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BOSER |
| Manufacturer Street | 5420 FELTL ROAD |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9524266141 |
| Manufacturer G1 | UROPLASTY, LLC |
| Manufacturer Street | 5420 FELTL ROAD |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MACROPLASTIQUE IMPLANTS |
| Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Product Code | LNM |
| Date Received | 2019-04-25 |
| Model Number | MPQ-2.5 |
| Catalog Number | MPQ-2.5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROPLASTY, LLC |
| Manufacturer Address | 5420 FELTL ROAD MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-25 |