MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-06-22 for VALSURE ENZYMATIC CLEANER manufactured by Steris Corporation.
[16855020]
The user facility reported an employee experienced breathing difficulties and a skin rash after exposure to valsure enzymatic cleaner. The employee subject of the reported event sought medical treatment.
Patient Sequence No: 1, Text Type: D, B5
[17108739]
The employee subject of the reported event sought medical treatment. The employee had an allergy skin patch test performed which yielded (b)(6) results to fragrance, cinnamic aldehyde, and oleamidopropyl dimethylamine. Although these chemicals are not present in valsure enzymatic cleaner, sensitive individuals may experience allergic reactions to the product. The employee has returned to modified work duties and the employee was wearing proper ppe at the time of the reported event. Steris was unable to confirm whether there was sufficient ventilation per the ansi/aami recommendations. Section 3. 4. 2 of ansi/aami st58:2005/(r)2010 regarding the ventilation of processing areas and equipment states, "general room ventilation: chemical sterilants should be used in an area that is properly ventilated. Rooms in which chemical disinfection and sterilization are performed should be large enough to ensure adequate dilution of vapor and should have a minimum air exchange rate of (b)(6) air exchanges per hour (local regulations may require a higher minimum exchange rate). Ideally, local exhaust ventilation should be located at the level of the point of discharge of the vapors and pull vapors away from the work area and not toward personnel in the room. " the instructions for use and label for valsure enzymatic cleaner states, "danger: contains: citric acid, ethanolamine. Causes skin irritation. Causes serious eye irritation. May cause allergy or asthma symptoms or breathing difficulties if inhaled. Avoid breathing mist, vapours, spray. Wash hands thoroughly after handling. Wear protective gloves, protective clothing, eye protection. If on skin: wash with plenty of water. If inhaled: remove person to fresh air and keep comfortable for breathing. " first aid measures of the material safety data sheet states, "symptoms/injuries: causes irritation. May cause an allergic reaction in sensitive individuals," and "may cause allergy or asthma symptoms or breathing difficulties if inhaled. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1937531-2015-00006 |
| MDR Report Key | 4859698 |
| Report Source | 06 |
| Date Received | 2015-06-22 |
| Date of Report | 2015-06-22 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-06-01 |
| Date Added to Maude | 2015-06-22 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | VALSURE ENZYMATIC CLEANER |
| Generic Name | CLEANER |
| Product Code | FLG |
| Date Received | 2015-06-22 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2015-06-22 |