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 |