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

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.

• 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 Key: 7895708
• MDR Text Key: 120964792
• Report Number: 9615010-2018-00013
• Device Sequence Number: 1
• Product Code: KYT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• 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

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 304121-9851-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 79