MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-09 for 1.5T QUADRATURE LOWER EXTREMITY COIL 9896-031-07421 manufactured by Invivo Corporation.
Report Number | 1056069-2020-00001 |
MDR Report Key | 9570027 |
Report Source | DISTRIBUTOR |
Date Received | 2020-01-09 |
Date of Report | 2020-01-07 |
Date Mfgr Received | 2019-12-10 |
Device Manufacturer Date | 2001-09-10 |
Date Added to Maude | 2020-01-09 |
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 | 1.5T QUADRATURE LOWER EXTREMITY COIL |
Generic Name | 1.5T QUADRATURE LOWER EXTREMITY COIL |
Product Code | LNH |
Date Received | 2020-01-09 |
Returned To Mfg | 2019-12-20 |
Model Number | 9896-031-07421 |
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 | 2020-01-09 |