MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for HEMI GREAT TOE IMPLANT 375-0002 manufactured by Osteomed.
Report Number | 2027754-2019-00009 |
MDR Report Key | 8691793 |
Date Received | 2019-06-12 |
Date of Report | 2019-05-15 |
Date of Event | 2019-05-17 |
Date Mfgr Received | 2019-05-15 |
Date Added to Maude | 2019-06-12 |
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. LATOIA PHILLIPS |
Manufacturer Street | 3885 ARAPAHO ROAD |
Manufacturer City | ADDISON TX 75001 |
Manufacturer Country | US |
Manufacturer Postal | 75001 |
Manufacturer G1 | OSTEOMED |
Manufacturer Street | 3885 ARAPAHO RD |
Manufacturer City | ADDISON TX 75001 |
Manufacturer Country | US |
Manufacturer Postal Code | 75001 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | HEMI GREAT TOE IMPLANT |
Generic Name | HEMI GREAT TOE IMPLANT, SMALL |
Product Code | KWD |
Date Received | 2019-06-12 |
Model Number | 375-0002 |
Catalog Number | 375-0002 |
Lot Number | 1131134 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | OSTEOMED |
Manufacturer Address | 3885 ARAPAHO ROAD ADDISON TX 75001 US 75001 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-06-12 |