MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-06-21 for GM11009520 INTERSTITIAL NEEDLES manufactured by Varian Medical Systems.
Report Number | 1124791-2019-00001 |
MDR Report Key | 8722013 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2019-06-21 |
Date of Report | 2019-08-14 |
Date of Event | 2019-05-22 |
Date Mfgr Received | 2019-05-23 |
Date Added to Maude | 2019-06-21 |
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 | MR. K. SEMONE |
Manufacturer Street | 911 HANSEN WAY |
Manufacturer City | PALO ALTO CA 943041028 |
Manufacturer Country | US |
Manufacturer Postal | 943041028 |
Manufacturer Phone | 6504246833 |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Removal Correction Number | 2916710-07/11/2019-001R |
Event Type | 3 |
Type of Report | 3 |
Brand Name | GM11009520 INTERSTITIAL NEEDLES |
Generic Name | GM11009520 INTERSTITIAL NEEDLES |
Product Code | JAQ |
Date Received | 2019-06-21 |
Model Number | GM11009520 |
Catalog Number | GM11009520 |
Lot Number | R43,S46,T11,T15,T28,T39T48,U13 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | VARIAN MEDICAL SYSTEMS |
Manufacturer Address | 501 LOCUST AVE #1 CHARLOTTESVILLE VA 22902 US 22902 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-06-21 |