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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUMENIS, INC. LIGHTSHEER DUET INTENSE PULSE LIGHT DELIVERY DEVICE: DIODE

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LUMENIS, INC. LIGHTSHEER DUET INTENSE PULSE LIGHT DELIVERY DEVICE: DIODE Back to Search Results
Model Number DUET
Device Problem Insufficient Information (3190)
Patient Problem Scarring (2061)
Event Date 06/09/2011
Event Type  Injury  
Event Description

It was reported that two patients sustained scars to the axilla following treatment with a lumenis lightsheer duet laser in poland. It was further reported the patients remained under the care of a physician.

 
Manufacturer Narrative

A lumenis healthcare professional evaluated the reported event details including treatment settings and patient photographs concluding that the treatment settings were appropriate for the reported procedures. Lumenis has requested service records from the distributor in poland; however no records have been received. Lumenis is unable to make a determination of cause. Should service records or other information be provided, lumenis will submit a follow-up mdr. Device not received for evaluation.

 
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Brand NameLIGHTSHEER DUET
Type of DeviceINTENSE PULSE LIGHT DELIVERY DEVICE: DIODE
Manufacturer (Section D)
LUMENIS, INC.
3959 west 1820 south
salt lake city UT 84104
Manufacturer (Section G)
LUMENIS, INC.
3959 west 1820 south
salt lake city UT 84104
Manufacturer Contact
steven kachocki
3959 west 1820 south
salt lake city, UT 84104
8015863647
MDR Report Key2217628
MDR Text Key2165932
Report Number1720381-2011-00042
Device Sequence Number1
Product Code GEX
Combination Product (Y/N)N
Reporter Country CodePL
PMA/PMN NumberK053628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 08/19/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDUET
Device Catalogue NumberGASB00000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/20/2011
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/19/2011 Patient Sequence Number: 1
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