MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-04 for VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH 4000593-51 manufactured by Sentinelle Medical.
[15264753]
Two (2) pts were reported by site to have rec'd minor skin affects: pt reported bruising [site reported as yellow bruising (2 black and blue marks) approx 2 inches long in area of abdomen below the breast]. Pt had red skin streaks/marks [as this is a normal and expected effect from device use, no further action taken] after breast mri exam using the sentinelle vanguard breast mri system. Sentinelle requested system be returned for investigation of pad positioning/placement by the user. Site confirmed that there was no treatment or intervention required for both the skin streaking and/or the bruising.
Patient Sequence No: 1, Text Type: D, B5
[15546761]
Sentinelle breast mri system was returned from site for eval on (b)(4) 2013. The tabletop and padding was examined. A seam at the bottom edge of the ramp pad was identified as a potential cause of pt discomfort, but was not considered a contributing factor to the skin streaking / bruising. Sentinelle applications personnel to provide add'l training/instruction on pt set-up and pad positioning to affected site. No causal effect can be determined between the skin streaking / bruising and the failure of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005748597-2013-00001 |
| MDR Report Key | 3150111 |
| Report Source | 05,06 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-06-04 |
| Date of Event | 2013-05-10 |
| Date Mfgr Received | 2013-05-10 |
| Date Added to Maude | 2013-06-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOAN MEDLEY, DIRECTOR, QUALITY |
| Manufacturer Street | 555 RICHMOND STREET WEST SUITE 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 | 2013-06-04 |
| Returned To Mfg | 2013-05-31 |
| Model Number | 4000593-51 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENTINELLE MEDICAL |
| Manufacturer Address | 555 RICHMOND STREET WEST SUITE 800 TORONTO, ON M5V3B1 CA M5V 3B1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-04 |