MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-12 for CRANIOSCULPT FLOW, 5CC C-FLOW5CC manufactured by Skeletal Kinetics.
| Report Number | 2027754-2020-00001 |
| MDR Report Key | 9701797 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-12 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-21 |
| Device Manufacturer Date | 2018-11-06 |
| Date Added to Maude | 2020-02-12 |
| 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 | MRS. FLOR RIVERA |
| Manufacturer Street | 3885 ARAPAHO ROAD |
| Manufacturer City | ADDISON, TX |
| Manufacturer Country | US |
| Manufacturer G1 | SKELETAL KINETICS |
| Manufacturer Street | 3885 ARAPAHO ROAD |
| Manufacturer City | ADDISON, TX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRANIOSCULPT FLOW, 5CC |
| Generic Name | BONE VOID FILLER |
| Product Code | PJM |
| Date Received | 2020-02-12 |
| Catalog Number | C-FLOW5CC |
| Lot Number | 1129763 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SKELETAL KINETICS |
| Manufacturer Address | 3885 ARAPAHO ROAD ADDISON, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |