MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-20 for EYEMAG LIGHT II N/A 304121-9851-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[120964792]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00013 |
| MDR Report Key | 7895708 |
| Date Received | 2018-09-20 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-08-23 |
| Date Added to Maude | 2018-09-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN, BADEN-WUERTTEMBERG 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EYEMAG LIGHT II |
| Generic Name | LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED |
| Product Code | KYT |
| Date Received | 2018-09-20 |
| Model Number | N/A |
| Catalog Number | 304121-9851-000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-20 |