MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-03 for EYEMAG LIGHT SUPPLY UNIT 304121-9002-000 manufactured by Carl Zeiss Meditec Ag.
[19592382]
The site reported that near the end of a surgical procedure performed using the eyemag pro light led illumination system liquid leaked from the battery pack, burned through the surgeon's pants and underwear, and contacted his skin. It was further reported that the surgeon sustained a third degree full thickness 1 x 3 cm burn on his right anterior thigh for which he did not seek medical attention. The burn left a permanent scar on his skin.
Patient Sequence No: 1, Text Type: D, B5
[19820708]
A field service engineer (fse) performed an on-site inspection. It was reported that battery leakage was due to using non-rechargeable batteries. Site contact information: same as initial reporter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615010-2014-00007 |
| MDR Report Key | 3687718 |
| Report Source | 05,06 |
| Date Received | 2014-03-03 |
| Date of Report | 2014-03-03 |
| Date of Event | 2013-09-26 |
| Date Mfgr Received | 2014-02-08 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2014-03-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUDY BRIMACOMBE |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 5574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG |
| Manufacturer Street | CARL ZEISS STRASSE 22 |
| Manufacturer City | OBERKOCHEN 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EYEMAG LIGHT SUPPLY UNIT |
| Generic Name | LOUPE, DIAGNOSTIC/SURGICAL |
| Product Code | FSP |
| Date Received | 2014-03-03 |
| Model Number | NA |
| Catalog Number | 304121-9002-000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG |
| Manufacturer Address | OBERKOCHEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-03 |