MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-10 for DS HEADNECK COIL 3.0T 9896-032-08031 manufactured by Carma Salud, S.l..
[130037504]
The investigation is still ongoing for this event. When the investigation is complete a follow-up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[130037505]
While being scanned, mirror assembly was attached to the mri coil. A screw had previously fell out of the assembly and during the scan the mirror dislodged from the assembly and fell to hit the patient's eye. No medical intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056069-2018-00006 |
| MDR Report Key | 8147940 |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-03 |
| Date Mfgr Received | 2018-11-26 |
| Device Manufacturer Date | 2018-02-08 |
| Date Added to Maude | 2018-12-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KENNETH REVENNAUGH |
| Manufacturer Street | C/ DISC |
| Manufacturer City | MADRID 28022 |
| Manufacturer Country | SP |
| Manufacturer Postal | 28022 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DS HEADNECK COIL 3.0T |
| Generic Name | DS HEADNECK COIL 3.0T |
| Product Code | MOS |
| Date Received | 2018-12-10 |
| Model Number | 9896-032-08031 |
| Catalog Number | 9896-032-08031 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARMA SALUD, S.L. |
| Manufacturer Address | C/ DISC?BOLO, 91-P4-2?A MADRID 28022 SP 28022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-10 |