MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-12-16 for ENVIROSYSTEMS ETHYLENE OXIDE STERILANT manufactured by Steris Corporation.
[33670059]
Steris became aware of the reported incident through a chemtrec incident report on november 17, 2015. The customer reported a burning sensation on his hands and in his eyes after removing items from the sterilizer. The individual washed his hands and flushed his eyes with water and stated that after these actions were completed, the burning sensations stopped. No medical treatment was sought or administered. The employee then placed gloves on his hands and removed the remaining items from the sterilizer. The employee was not initially wearing gloves upon removal of the instruments. A material safety data sheet (msds) was provided to the facility which addresses exposure controls when working with envirosystems ethylene oxide sterilant. The msds states, "8. 2 hand protection: wear protective gloves. Use neoprene gloves. Use gloves constructed of chemical resistant materials such as heavy nitrile rubber if frequent or prolonged contact is expected. In addition, "eye protection: wear protective eyewear. Eye protection, including both chemical splash goggles and face shield, must be worn when possibility exists for eye contact due to spraying liquid or airborne particles. Do not wear contact lenses. " the customer has reported feeling fine with no sustained pain or discomfort. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[33670060]
The customer reported that ethylene oxide sterilant was used in a sterilizer and upon removal of the sterilized instruments; the customer experienced burning in his eyes and irritation on his hands.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2015-00016 |
| MDR Report Key | 5303511 |
| Report Source | OTHER |
| Date Received | 2015-12-16 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-11-17 |
| Date Mfgr Received | 2015-11-17 |
| Date Added to Maude | 2015-12-16 |
| 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 | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CORPORATION |
| Manufacturer Street | 7501 PAGE AVENUE |
| Manufacturer City | ST. LOUIS MO 63133 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63133 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENVIROSYSTEMS ETHYLENE OXIDE STERILANT |
| Generic Name | STERILANT |
| Product Code | FLF |
| Date Received | 2015-12-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 7501 PAGE AVENUE ST. LOUIS MO 63133 US 63133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-16 |