MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-16 for PUREGRAFT 850 SYSTEM 101-014-02 850/PURE-INT manufactured by Puregraft Llc.
Report Number | 3011277972-2019-00002 |
MDR Report Key | 8794513 |
Report Source | DISTRIBUTOR |
Date Received | 2019-07-16 |
Date of Report | 2019-07-11 |
Date Mfgr Received | 2019-06-14 |
Device Manufacturer Date | 2018-07-01 |
Date Added to Maude | 2019-07-16 |
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. OLIVIA KIM |
Manufacturer Street | 420 STEVENS AVE. SUITE 220 |
Manufacturer City | SOLANA BEACH CA 92075 |
Manufacturer Country | US |
Manufacturer Postal | 92075 |
Manufacturer Phone | 8583488050 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PUREGRAFT 850 SYSTEM |
Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
Product Code | MUU |
Date Received | 2019-07-16 |
Model Number | 101-014-02 |
Catalog Number | 850/PURE-INT |
Lot Number | 00052115 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | PUREGRAFT LLC |
Manufacturer Address | 420 STEVENS AVE. SUITE 220 SOLANA BEACH CA 92075 US 92075 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-07-16 |