MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-06 for ARTHROSURFACE TOEMOTION manufactured by Arthrosurface, Inc..
Report Number | 3004154314-2020-00001 |
MDR Report Key | 9678288 |
Report Source | CONSUMER |
Date Received | 2020-02-06 |
Date of Report | 2020-01-09 |
Date Mfgr Received | 2020-01-09 |
Date Added to Maude | 2020-02-06 |
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 | MR. PHANI PUPPALA |
Manufacturer Street | 28 FORGE PARKWAY |
Manufacturer City | FRANKLIN, MA 02038 |
Manufacturer Country | US |
Manufacturer Postal | 02038 |
Manufacturer Phone | 5085203003 |
Manufacturer G1 | PRIMO MEDICAL GROUP |
Manufacturer Street | 75 MILL ST |
Manufacturer City | STOUGHTON, MA MA 02072 |
Manufacturer Country | US |
Manufacturer Postal Code | 02072 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ARTHROSURFACE TOEMOTION |
Generic Name | ARTHROSURFACE? TOTAL TOE - PROXIMAL PHALANX IMPLANT |
Product Code | LZJ |
Date Received | 2020-02-06 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ARTHROSURFACE, INC. |
Manufacturer Address | 28 FORGE PARKWAY FRANKLIN, MA 02038 US 02038 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-02-06 |