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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LS PRO SYSTEMS LS PRO SYSTEMS LOW LEVEL LIGHT THERAPY; LAMP, INFRARED, THERAPEUTIC HEATING
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LS PRO SYSTEMS LS PRO SYSTEMS LOW LEVEL LIGHT THERAPY; LAMP, INFRARED, THERAPEUTIC HEATING Back to Search Results
Model Number LSG 264
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 07/13/2018
Event Type  malfunction  
Event Description
Product overheated and burnt patient during use.The low level laser therapy was advertised as fda approved during trade show.It has come to my attention under further investigation.The units were fda approved and have had 3 incidents of overheating.This has been the most significant.Name and strength: lsg 264, not sure anymore unk.Dose or amount: 2an; frequency: daily.Dates of use: (b)(6) 2018 to (b)(6) 2018.Diagnosis or reason for use: to heal patient's wounds."is the product compounded: no.Is the product over-the-counter: no." event abated after use stopped or dose reduced: yes.Event reappeared after reintroduction: yes.
 
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Brand Name
LS PRO SYSTEMS LOW LEVEL LIGHT THERAPY
Type of Device
LAMP, INFRARED, THERAPEUTIC HEATING
Manufacturer (Section D)
LS PRO SYSTEMS
MDR Report Key7697760
MDR Text Key114537197
Report NumberMW5078463
Device Sequence Number1
Product Code ILY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberLSG 264
Device Catalogue NumberLSG GENERAL PAD
Device Lot Number
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age27 YR
Patient Weight77
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