MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-27 for TRUMATCH CT CUT GUIDE KIT R 420916 manufactured by Depuy Ireland - 9616671.
| Report Number | 1818910-2020-03049 |
| MDR Report Key | 9633328 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-14 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-12-16 |
| Date Added to Maude | 2020-01-27 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER PA 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655 |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUMATCH CT CUT GUIDE KIT R |
| Generic Name | TRUMATCH INSTRUMENTS : RESECTION BLOCKS/DEVICES |
| Product Code | FSM |
| Date Received | 2020-01-27 |
| Returned To Mfg | 2020-01-24 |
| Model Number | 420916 |
| Catalog Number | 420916 |
| Lot Number | 21219 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-27 |