MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-06-29 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.
[112721690]
Information was found during a routine literature search as an abstract. Uroplasty has been in contact with one of the abstract's authors, however no additional information has been provided to us at this time.
Patient Sequence No: 1, Text Type: N, H10
[112721691]
A (b)(6) year old male with mild persistent stress urinary incontinence (sui) after a radical prostatectomy underwent elective intraureteral bulking agent injections. After the initial mild improvement, the sui progressed and the patient required 5 diapers a day. The patient subsequently had an artificial urinary sphincter (aus) placement with improvement of his leakage. Two years later, the patient represented with worsening sui despite normal aus function. Upon urethroscopy, it was discovered that the patient had urethral erosion with crystals that enveloped his cuff. These were found to be macroplastique type crystals during pathologic evaluation. Three additional procedures, including aus removal, open and endoscopic procedures were required to remove residual macroplastique crystals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2018-00006 |
| MDR Report Key | 7650146 |
| Report Source | LITERATURE |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-27 |
| Date Mfgr Received | 2018-02-12 |
| Date Added to Maude | 2018-06-29 |
| 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 | 3 |
| Brand Name | MACROPLASTIQUE IMPLANTS |
| Generic Name | URETHERAL BULKING AGENT |
| Product Code | LNM |
| Date Received | 2018-06-29 |
| Model Number | MPQ-2.5 |
| Catalog Number | MPQ-2.5 |
| 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. Other | 2018-06-29 |