MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-02-16 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.
[100511729]
In a recent publication in the international urogynecology journal, it was noted that a female patient experienced migration of the mpq implant to her bladder. A postmenopausal woman had an mpq injection for incontinence in 2011. In 2014, she was diagnosed with bladder carcinoma and underwent transurethral resection of a bladder tumor. During a surveillance cystoscopy, an irregular area in the trigone of the bladder was noted, and resected by urology in 2016. Pathology of the mass returned as a foreign body giant cell reaction with refractile gel-like material consistent with mpq.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2018-00002 |
| MDR Report Key | 7278187 |
| Report Source | LITERATURE |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-15 |
| Date Mfgr Received | 2018-01-19 |
| Date Added to Maude | 2018-02-16 |
| 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 | 2018-02-16 |
| Model Number | MPQ-2.5 |
| Catalog Number | MPQ-2.5 |
| Device Availability | * |
| 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 | 2018-02-16 |