MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-19 for MACROPLASTIQUE IMPLANTS MPQ-2.5 manufactured by Uroplasty, Llc.
Report Number | 3002647932-2019-00004 |
MDR Report Key | 8807022 |
Date Received | 2019-07-19 |
Date of Report | 2019-07-18 |
Date of Event | 2019-01-07 |
Date Mfgr Received | 2019-07-02 |
Date Added to Maude | 2019-07-19 |
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 | MACROPLASTIQUE |
Product Code | LNM |
Date Received | 2019-07-19 |
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 | 2019-07-19 |