MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-05 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.
[119650074]
Some of the macroplastique material was removed when removing the bladder stone which occurred at the site of implantation. Per conversations with the initial reporter (dr. (b)(6)), most of the macroplastique material still remains in the patient.
Patient Sequence No: 1, Text Type: N, H10
[119650075]
A female patient received macroplastique injections in 2013, having previously undergone midureteral mesh sling without improvement in her urinary incontinence. She presented recently with a 12 month history of progressive "vaginal" pain, especially following voiding. She was found on cystoscopy to have a bladder stone adherent to eroded material (macroplastique) at her right bladder neck. The bladder stone was treated endoscopically with a holmium laser, and some of the macroplastique implant was pulled out with the use of endoscopic grasping forceps. Most of the macroplastique was left behind.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2018-00007 |
| MDR Report Key | 7847007 |
| Date Received | 2018-09-05 |
| Date of Report | 2018-09-05 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-09-05 |
| 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 | 2018-09-05 |
| 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 | 2018-09-05 |