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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENTINELLE MEDICAL VANGUARD BREAST MRI AUXILLIARY TABLE WITH 8 CH COIL, MAGNETIC RESONANCE, SPECIALTY

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SENTINELLE MEDICAL VANGUARD BREAST MRI AUXILLIARY TABLE WITH 8 CH COIL, MAGNETIC RESONANCE, SPECIALTY Back to Search Results
Model Number 4000001-11
Event Date 10/21/2010
Event Type  Other  
Event Description

One pt underwent a breast mri exam using the sentinelle breast coil, ge signa 1. 5t mri scanner, and senorx 7-gauge biopsy needle. Pt returned to the emergency department three (3) days post procedure for treatment of two 3rd degree burns. One (1) burn was approx a quarter-size and situated just below the incision. Other (2) burns were situated above the biopsy incision and was pin-head in size. Site reported using their system since the incident without any adverse events, problems, or failures. Sentinelle service personnel, dispatched to site to investigate, inspect and test the affected breast coils to determine any association between the device and the event.

 
Manufacturer Narrative

The device was inspected by sentinelle service personnel post event. No component or system faults were identified during the inspection. Device history record (dhr) review was conducted on the identified (b)(4). No failures or abnormalities were found related to the reported info. The device passed final test and inspection prior to release. There is no known association between the event and the device. Results: no foreign substances or amounts of blood found anywhere on coils or frames. Summary: the product performed as intended during inspection and testing. No foreign substances or amounts of blood were found anywhere on coils or frames. The reported complaint and adverse event cannot be confirmed. This observation will be monitored and trended.

 
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Brand NameVANGUARD BREAST MRI AUXILLIARY TABLE WITH 8 CH
Type of DeviceCOIL, MAGNETIC RESONANCE, SPECIALTY
Manufacturer (Section F)
SENTINELLE MEDICAL
555 richmond street west
suite 800
toronto, on
CANADA M5V 3B1
Manufacturer (Section D)
SENTINELLE MEDICAL
555 richmond street west
suite 800
toronto, on
CANADA M5V 3B1
Manufacturer Contact
joan medley, director
555 richmond street west
suite 800
toronto, on  
CANADA   M5V 3B1
647 258 3607
Device Event Key1959225
MDR Report Key1929795
Event Key1826791
Report Number3005748597-2010-00002
Device Sequence Number1
Product CodeMOS
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/26/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number4000001-11
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received11/03/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/27/2010 Patient Sequence Number: 1
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