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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) EYEMAG LIGHT II; LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED

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CARL ZEISS MEDITEC AG (OBERKOCHEN) EYEMAG LIGHT II; LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED Back to Search Results
Model Number N/A
Device Problems Overheating of Device (1437); Temperature Problem (3022); Excessive Heating (4030)
Patient Problems Scarring (2061); Partial thickness (Second Degree) Burn (2694)
Event Date 08/03/2018
Event Type  Injury  
Event Description
It was reported that during a procedure, the battery pack of the eyemag light ii worn by a doctor became hot and burned him on his abdomen area.It was reported that the burn was 15mm x 7mm, had a fluid filled blister, and was accompanied by redness and soreness.The doctor did not seek any medical attention.Photos submitted by the user facility showed a dark scar on the doctor's skin.
 
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Brand Name
EYEMAG LIGHT II
Type of Device
LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED
Manufacturer (Section D)
CARL ZEISS MEDITEC AG (OBERKOCHEN)
rudolf-eber-strasse 11
oberkochen, baden-wuerttemberg 73447
GM  73447
Manufacturer (Section G)
CARL ZEISS MEDITEC AG (OBERKOCHEN)
rudolf-eber-strasse 11
oberkochen, baden-wuerttemberg 73447
GM   73447
Manufacturer Contact
william gustafson
5160 hacienda drive
dublin, CA 94568
9255574689
MDR Report Key7895708
MDR Text Key120964792
Report Number9615010-2018-00013
Device Sequence Number1
Product Code KYT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 08/23/2018
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
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number304121-9851-000
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/23/2018
Initial Date FDA Received09/20/2018
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age42 YR
Patient Weight79
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