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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RIVERPOINT MEDICAL SAPPHIRE
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RIVERPOINT MEDICAL SAPPHIRE Back to Search Results
Model Number MLS01
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 11/02/2015
Event Type  Injury  
Manufacturer Narrative
The use conditions were reproduced by distributor and the unit did not become hot, the reported issue could not be recreated.Device history files for this product code were reviewed and no issues identified.No conclusion can be drawn at this time, the device will be returned to the manufacturer for additional testing and a supplemental 3500a will be submitted accordingly.
 
Event Description
The unit became hot and burned the users right upper ear.The burn was treated and there was no other reported issues at this time.
 
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Brand Name
SAPPHIRE
Type of Device
SAPPHIRE
Manufacturer (Section D)
RIVERPOINT MEDICAL
825 ne 25th ave
portland OR 97232
Manufacturer Contact
edwin anderson
825 ne 25th ave
portland, OR 97232
5035178001
MDR Report Key5270378
MDR Text Key32824069
Report Number3006981798-2015-00004
Device Sequence Number1
Product Code FSR
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 12/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberMLS01
Device Catalogue NumberMLS01
Device Lot Number130627-00007300
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/02/2015
Initial Date FDA Received12/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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