MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-02 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.
[101615830]
Several attempts were made to get more information regarding the incident. The incident is being reported as an adverse event since the mucosa was perforated, exposing the mpq, which may have let to the stone formation. At this point, we are considering the removal of the stone to be medical intervention to preclude permanent damage to a body structure or reforming bladder stones.
Patient Sequence No: 1, Text Type: N, H10
[101616151]
Female patient who presented with urinary incontinence was initially treated via pubovaginal sling in 2005. In (b)(6) 2013, patient was given a suburethral injection of macroplastique (mpq) with good results and follow up through 2014. In (b)(6) 2017, the patient was referred back to her doctor for possible bladder stones - the patient reported mild bladder irritability and minor recurrent stress urinary incontinence (sui). The patient was found to have mucosa which had perforated exposing the mpq implant, and also had a bladder stone which developed on top of the exposed mpq implant. The patient underwent a cystolitholapaxy in (b)(6) 2017 to remove the bladder stones. It is unclear if the mpq implant was removed, or if other treatment was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2018-00004 |
| MDR Report Key | 7310369 |
| Date Received | 2018-03-02 |
| Date of Report | 2018-03-02 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2018-03-02 |
| 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 | URETHRAL BULKING AGENT |
| Product Code | LNM |
| Date Received | 2018-03-02 |
| 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 | 1. Required No Informationntervention | 2018-03-02 |