MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-27 for 10MM, 06?, LUNA IMPLANT, PEEK LUN20006-10 manufactured by Benvenue Medical, Inc..
Report Number | 3007033608-2019-00007 |
MDR Report Key | 9386611 |
Report Source | USER FACILITY |
Date Received | 2019-11-27 |
Date of Report | 2019-10-27 |
Date of Event | 2019-10-28 |
Date Mfgr Received | 2019-10-28 |
Device Manufacturer Date | 2019-05-28 |
Date Added to Maude | 2019-11-27 |
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 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. LAURENT SCHALLER |
Manufacturer Street | 4590 PATRICK HENRY DRIVE |
Manufacturer City | SANTA CLARA CA 95054 |
Manufacturer Country | US |
Manufacturer Postal | 95054 |
Manufacturer Phone | 4084549300 |
Manufacturer G1 | BENVENUE MEDICAL, INC. |
Manufacturer Street | 4590 PATRICK HENRY DRIVE |
Manufacturer City | SANTA CLARA CA 95054 |
Manufacturer Country | US |
Manufacturer Postal Code | 95054 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | 10MM, 06?, LUNA IMPLANT, PEEK |
Generic Name | 10MM, 06?, LUNA IMPLANT, PEEK |
Product Code | MAX |
Date Received | 2019-11-27 |
Returned To Mfg | 2019-09-20 |
Model Number | LUN20006-10 |
Catalog Number | LUN20006-10 |
Lot Number | 19141006 |
Device Expiration Date | 2019-11-28 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BENVENUE MEDICAL, INC. |
Manufacturer Address | 4590 PATRICK HENRY DRIVE SANTA CLARA CA 95054 US 95054 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-27 |