MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2015-05-01 for TOSHIBA MJAB-137A/S1 manufactured by Toshiba Medical Systems Corporation.
[5887052]
A patient allegedly sustained two quarter-sized areas of redness and tenderness bilaterally at the anterior, superior spine during an mri scan.
Patient Sequence No: 1, Text Type: D, B5
[13327023]
A patient was scanned for a pelvis and lower extremity, thigh to knee in a toshiba mri system using a qd torso speeder coil. Allegedly the patient complained of a warming sensation in her pelvic region when contrast was injected. The patient allegedly sustained two quarter-sized areas of redness and tenderness bilaterally at the area of the anterior, superior spine. The patient was examined by a physician and an rn and no blistering was seen. Follow-up calls were placed to the patient at 6 and 24 hours later. At 6 hours no worsening and at 24 hours the patient indicated that the tenderness was gone and redness was slowly dissipating. The coil was inspected one day following the scan and no physical damage was noted. Qa scans for the coil were performed and it did not meet one of the specifications but is not related to the event. The coil is being replaced for the customer and the original coil is being returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[32774524]
The coil was returned to the manufacturer for investigation. It was determined that the cause of the problem was damage to the anterior connector of the coil. It is believed that the damage to the anterior connector caused the feet scan of the coil to not meet the snr specification. This in turn caused the surface temperature of the coil to rise, causing the burn to the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020563-2015-00002 |
| MDR Report Key | 4743749 |
| Report Source | 05,06,07 |
| Date Received | 2015-05-01 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-04-02 |
| Date Added to Maude | 2015-05-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. PAUL BIGGINS |
| Manufacturer Street | 2441 MICHELLE DRIVE |
| Manufacturer City | TUSTIN CA 92780 |
| Manufacturer Country | US |
| Manufacturer Postal | 92780 |
| Manufacturer Phone | 7147305000 |
| Manufacturer G1 | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 1385 SHIMOISHIGAMI |
| Manufacturer City | OTAWARA-SHI, TOCHIGI 324-8550 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 324-8550 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSHIBA |
| Generic Name | MAGNETIC RESONANCE COIL |
| Product Code | MOS |
| Date Received | 2015-05-01 |
| Model Number | MJAB-137A/S1 |
| Operator | RADIOLOGIC TECHNOLOGIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 1385 SHIMOISHIGAMI OTAWARA-SHI, TOCHIGI 324-8550 JA 324-8550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-01 |