MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for MACROPLASTIQUE IMPLANTS manufactured by Uroplasty, Llc.
[144824333]
Macroplastique implants are not indicated for treatment of vur within the united states (only female sui), however the vur inidication exists for all geographies outside 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 mpq was reqmoved 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. Additionally, this report is being submitted to fda more than 30 days after the initial awareness date as the literature was published in (b)(4) and translations of the article were necessary in order to evalute whether or not the event described was reportable.
Patient Sequence No: 1, Text Type: N, H10
[144824334]
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) year old man received mpq treatment for vur 7 years previous. Micturating cystourethrography had shown that the vur had disappeared. The patient presented with left abdominal pain as a main complaint. No hydronephrosis was shown in computer tomography however an approximately 8. 3 mm sized stone was shown in the left vesicoureteral junction near where the mpq had been previously injected. Ureteral endoscopy showed a protuberant granulation tissue inside the bladder directly below the left ureteral orifice which was firmly attached to the stone. The stones were removed via holmium: yag laser, crushed and then removed from the patient's body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2019-00003 |
| MDR Report Key | 8595744 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-08 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-05-09 |
| 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 | 2019-05-09 |
| 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 | 2019-05-09 |