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.
[145648746]
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
[145648747]
This event was discovered during a literature search related to macroplastique (mpq) for treatment of vesicoureteral reflux (vur) and was found in the form of a case study. A (b)(6) male patient had undergone treatment with mpq when he was 9 months of age after being diagnosed with unilateral grade v vur. The patient presented with intermittent gross hematuria and supra-pubic pain for several months. The patient was treated with antibiotics for suspected cystitis and the symptoms disappeared within several days. Two years after the mpq injection, the patient presented with gross hematuria (four times) and microscopic hematuria (two times). Whenever hematuria was present, the patient's urine calcium/creatinine ratio was checked and results were normal. Urinalysis showed isomorphic hematuria and mild proteinuria. A ct scan was performed and showed two 0. 7 cm hyperdense lesions in the left posterior aspects of the bladder and suspected stones at the uvj or in the bladder. Ultrasonography showed previous mild pelvirectal of the left kidney (0. 3 cm) and two hyperechoic foci with posterior acoustic shadowing in the left posterior aspect of the bladder. A diagnostic cystoscopy was performed showing calcifications leading to mucosal erosions around the orifice where mpq had been previously injected. The calcifications on the mucosal area were successfully removed via laser, however it is unclear if any mpq was also removed at this time. The patient's symptoms were gradually relived after treatment and routine monitoring for seven months after the removal of the calcifications showed no recurrent symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2019-00002 |
| MDR Report Key | 8548960 |
| 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 |