MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-12 for BIOSTOP G CEM RESTR 14MM 546314000 manufactured by Depuy Cmw - 9610921.
| Report Number | 1818910-2019-98188 |
| MDR Report Key | 8785819 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-12 |
| Date of Report | 2019-06-21 |
| Date of Event | 2019-06-21 |
| Date Mfgr Received | 2019-10-30 |
| Device Manufacturer Date | 2018-12-06 |
| Date Added to Maude | 2019-07-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY CMW - 9610921 |
| Manufacturer Street | CORNFORD RD |
| Manufacturer City | BLACKPOOL FY4 4QQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | FY4 4QQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSTOP G CEM RESTR 14MM |
| Generic Name | DEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG |
| Product Code | JDK |
| Date Received | 2019-07-12 |
| Catalog Number | 546314000 |
| Lot Number | 18F1801009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY CMW - 9610921 |
| Manufacturer Address | CORNFORD RD BLACKPOOL FY4 4QQ UK FY4 4QQ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-12 |