MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-07 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.
[130030500]
Uroplasty is conservatively reporting each occurrence of this malfunction as a separate mdr based on the lack of information surrounding the incident, as well as the potential for the device to require explantation. The incidents were reported together directly to the (b)(6) and the reporter wished to remain anonymous. Uroplasty has contacted the distributor multiple times in an attempt to acquire additional information that could aid in performing an investigation, however due to privacy laws in (b)(6), very limited information on the actual incidents has been made available. Based on the information we were able to obtain, uroplasty is unable to discern what the potential cause of the erosion of the bulking agent is, however should further information be made available, we plan to update this report accordingly.
Patient Sequence No: 1, Text Type: N, H10
[130030501]
Three patients in (b)(6) presented with potential complications possibly related to prior implantation of macroplastique. All three patients had macroplastique implanted years earlier; the subject of this report had two injections: one in 1998 and the second in 2007. The patients presented with recurrent incontinence and urinary tract infections. The reporter noted that the bulking material was said to have been exposed/eroded through the epithelium of the bladder neck and/or urethra. The doctor attempted to remove the material, however if was said the macroplastique was impossible to remove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002647932-2018-00010 |
| MDR Report Key | 8143732 |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-06 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-12-07 |
| 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 | 2018-12-07 |
| 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 | 2018-12-07 |