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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV PHILIPS LUMEA COMFORT; IPL GEX
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PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV PHILIPS LUMEA COMFORT; IPL GEX Back to Search Results
Model Number SC1981/00
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code Eye Injury (1845)
Date of Event 03/21/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This is the first time this type of complaint has been received.It is not known if the consumer had a pre-existing condition that would have caused the diagnosis.The unit has been requested back from the consumer for investigation and analysis.Without an investigation of the actual unit, we are unable to confirm the complaint.
 
Event or Problem Description
Consumer claims that when using the device over her calf she pressed the button for a flash, but the flash did not come on instantly.She had time to pull the device and just at that time the flash occurred.She was looking directly into the light and saw white marks in her sight for a few hours.
 
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Brand Name
PHILIPS LUMEA COMFORT
Common Device Name
IPL GEX
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
boxchdijk 525
eindhoven, 5621 JG
NL  5621 JG
MDR Report Key5634002
Report Number3009226815-2016-00003
Device Sequence Number12359255
Product Code OHT
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K141242
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 03/25/2016
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? Yes
Operator of Device Lay User/Patient
Device Model NumberSC1981/00
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/25/2016
Initial Report FDA Received Date05/05/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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