MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-02-10 for QUADRATURE LOWER EXTREMITY COIL 9896-031-02462 manufactured by Invivo Corporation.
| Report Number | 1056069-2020-00002 |
| MDR Report Key | 9689805 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-15 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2009-09-16 |
| Date Added to Maude | 2020-02-10 |
| 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 | QUADRATURE LOWER EXTREMITY COIL |
| Generic Name | QUADRATURE LOWER EXTREMITY COIL |
| Product Code | LNH |
| Date Received | 2020-02-10 |
| Returned To Mfg | 2020-01-03 |
| Model Number | 9896-031-02462 |
| 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 | 2020-02-10 |