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 |