MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-12-11 for DS HEADNECK 3.0T 9896-032-16041 manufactured by Invivo Corporation.
| Report Number | 1056069-2019-00003 |
| MDR Report Key | 9453532 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-12-11 |
| Date of Report | 2019-12-09 |
| Date Mfgr Received | 2019-11-11 |
| Device Manufacturer Date | 2019-01-08 |
| Date Added to Maude | 2019-12-11 |
| 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. KENNETH REVENNAUGH |
| Manufacturer Street | 3545 SW 47TH AVE |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer G1 | PHILIPS HEALTHCARE - INVIVO DIAGNOSTIC IMAGING |
| Manufacturer Street | 3545 SW 47TH AVE |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32608 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DS HEADNECK 3.0T |
| Generic Name | DS HEADNECK 3.0T |
| Product Code | MOS |
| Date Received | 2019-12-11 |
| Returned To Mfg | 2019-12-09 |
| Model Number | 9896-032-16041 |
| Catalog Number | 9896-032-16041 |
| Lot Number | N/A |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORPORATION |
| Manufacturer Address | 3545 SW 47TH AVE GAINESVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-11 |