MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-09-11 for TIBIAL RESECTION BLOCK 7 DEG 249256000 manufactured by Depuy Orthopaedics Inc Us.
Report Number | 1818910-2019-103975 |
MDR Report Key | 8992325 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
Date Received | 2019-09-11 |
Date of Report | 2019-08-20 |
Date of Event | 2019-08-21 |
Date Mfgr Received | 2019-10-24 |
Device Manufacturer Date | 1999-01-15 |
Date Added to Maude | 2019-09-11 |
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 ORTHOPAEDICS, INC. 1818910 |
Manufacturer Street | 700 ORTHOPAEDIC DR. |
Manufacturer City | WARSAW IN 465810988 |
Manufacturer Country | US |
Manufacturer Postal Code | 465810988 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | TIBIAL RESECTION BLOCK 7 DEG |
Generic Name | KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES |
Product Code | HTZ |
Date Received | 2019-09-11 |
Returned To Mfg | 2019-08-30 |
Catalog Number | 249256000 |
Lot Number | AH0199 |
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 ORTHOPAEDICS INC US |
Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-09-11 |