MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.
[102207221]
The issue was discovered through a routine literature search. Several attempts were made to reach the author for more information regarding the event, however no response was received. It was noted that the patient received several repeat treatments with mpq despite limited improvement in her symptoms. This, coupled with the patient's history, may indicate that she was a poor candidate for treatment.
Patient Sequence No: 1, Text Type: N, H10
[102207222]
A (b)(6) year-old caucasian female first presented 20 years ago with bladder prolapse and genuine stress urinary incontinence (sui). After failing to improve on conservative management and colposuspension, she underwent a macroplastique (mpq) injection for persistent urodynamically confirmed sui. She experienced brief symptomatic improvement, but symptoms reoccurred within months, leading to three separate injections of mpq at six monthly intervals. Each of these injections had a similar outcome as previously, but after the final injection, her symptoms partially settled, but she experienced storage systems. Seven years ago, these storage systems worsened. A cystoscopy performed showed mucosal swellings with calcifications close to the bladder neck and the proximal urethra. The calcifications were resected, and histopathology showed foreign material without malignancy. The patient's sui did not deteriorate any further, however she developed urgency symptoms. Two years ago, patient was referred for non-visible haematuria with post-micturition pain. A cystoscopy revealed unhealthy areas close to the bladder neck that were resected. Histopathology showed only a foreign body reaction, and an ultrasound showed echogenic material in the bladder wall close to the bladder neck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2018-00003 |
| MDR Report Key | 7328022 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date Mfgr Received | 2017-11-16 |
| Date Added to Maude | 2018-03-09 |
| 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 | URETHERAL BULKING AGENT |
| Product Code | LNM |
| Date Received | 2018-03-09 |
| 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 | 2018-03-09 |