FDA Adverse Event
Malfunction
Summary report: N
MACROPLASTIQUE IMPLANTS
MDR report key: 7278187
·
Received February 16, 2018
Report
- Report Number
- 3002647932-2018-00002
- Event Type
- Malfunction
- Date Received
- February 16, 2018
- Report Date
- February 15, 2018
- Manufacturer
- UROPLASTY, LLC
- Product Code
- LNM
- UDI-DI
- 08717591240266
- PMA / PMN Number
- P040050
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119960 | MACROPLASTIQUE IMPLANTS | URETHERAL BULKING AGENT | LNM | UROPLASTY, LLC | MPQ-2.5 | 08717591240266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |