FDA Adverse Event Other Summary report: N

VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH

MDR report key: 3150111 · Received June 4, 2013

Report

Report Number: 3005748597-2013-00001
Event Type: Other
Date Received: June 4, 2013
Date of Event: May 10, 2013
Report Date: June 4, 2013
Manufacturer: SENTINELLE MEDICAL
Product Code: MOS
PMA / PMN Number: K100113
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
246729	VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH	COIL, MAGNETIC RESONANCE, SPECIALTY	MOS	SENTINELLE MEDICAL	4000593-51

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other