• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUMENIS LTD TOKNEAM ULTRAPULSE ENCORE AESTHETIC PACKAGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LUMENIS LTD TOKNEAM ULTRAPULSE ENCORE AESTHETIC PACKAGE Back to Search Results
Model Number 0642-415-01
Event Date 04/30/2008
Event Type  Injury  
Manufacturer Narrative

No device malfunction was reported by/or user facility. Observed by lumenis service investigations. Treatment parameters were confirmed to be within dfu thresholds. As this is the first reported event of this type and related product trending is available.

 
Event Description

It was reported that during a up encore treatment, the pt received a 2mm x 1 centimeter scar on her left lower eyelid and a 6mm x 1 centimeter scar on her right lower eyelid. Also, there is an ectropian on the left inner corner of her eye. The pt has been treated with steroid injections. Vbeam laser and silicon gel sheeting.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAPULSE ENCORE AESTHETIC PACKAGE
Type of DeviceULTRAPULSE ENCORE
Manufacturer (Section D)
LUMENIS LTD TOKNEAM
13 hayetzira st.
yokneam industrial park
yokneam IL 20692
Manufacturer (Section G)
LUMENIS LTD
13 hayetzira st.
yokneam industrial park
yokneam IL
Manufacturer Contact
isela stahr
5302 betsy ross dr.
santa clara , CA 95054
MDR Report Key1082248
Report Number2914019-2008-00031
Device Sequence Number1
Product CodeHQF
Report Source Manufacturer
Source Type User facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/24/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number0642-415-01
Device Catalogue Number0642-415-01
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was Device Evaluated By Manufacturer? Yes
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: 07/24/2008 Patient Sequence Number: 1
-
-