MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-10 for VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH 4000001-12 manufactured by Sentinelle Medical.
[18472460]
Pt received two (2) mild white blisters (surrounded by redness) on both thumb's during a breast mri exam. Pt reported feeling an electrical sensation running through her body during a breast mri scan. When examined by the radiologist two small areas of mild blistering were noted on the pt's left and right thumb. Site reported that due to large size of breasts, a higher field of view (fov) and increase in number of slices was required. Pt did not require intervention or treatment for blistering.
Patient Sequence No: 1, Text Type: D, B5
[18762068]
System has been in use for more than 4 years with this being the first report of pt receiving blisters, using the affected system. Sentinelle field engineer (fe) went on site to investigate affected system. Fe performed inspections and testing and reported that system was performing/functioning as expected. No causal effect can be determined between the adverse event (blistering) and the failure of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005748597-2013-00002 |
| MDR Report Key | 3358294 |
| Report Source | 05,06 |
| Date Received | 2013-09-10 |
| Date of Report | 2013-09-09 |
| Date of Event | 2013-08-20 |
| Date Mfgr Received | 2013-08-20 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2013-10-07 |
| 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 | JOAN MEDLEY, DIR |
| Manufacturer Street | 555 RICHMOND ST WEST STE 800 |
| Manufacturer City | TORONTO, ON M5V 3B1 |
| Manufacturer Country | CA |
| Manufacturer Postal | M5V 3B1 |
| Manufacturer Phone | 2583607 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH |
| Generic Name | COIL, MAGNETIC RESONANCE, SPECIALTY |
| Product Code | MOS |
| Date Received | 2013-09-10 |
| Model Number | 4000001-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENTINELLE MEDICAL |
| Manufacturer Address | 555 RICHMOND ST WEST SUITE 800 TORONTO, ON M5V3B1 CA M5V 3B1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-10 |