MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER manufactured by Steris Corporation.
[105774191]
Following the reported event, the user facility contacted steris. Steris immediately provided the user facility with the safety data sheet for prolystica 2x presoak and cleaner. During the time of the reported event, the employee was wearing short gloves while utilizing the cleaning product allowing the cleaning product to seep into their gloves and cause the reported event. The prolystica 2x presoak and cleaner safety data sheet states (pg. 3), "protective equipment, wear protective gloves, and eye/face protection. Avoid all unnecessary exposure. Personal protective equipment should be selected based upon the conditions under which this product is handled or used. Protective clothing, gloves, protective googles. " steris offered in-service training on the proper use of prolystica 2x presoak and cleaner and the user facility has declined this offer. Steris has made multiple attempts to contact the user facility for additional details on the employee's condition, however a response has not been received. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[105774192]
The user facility reported that an employee utilized prolystica 2x presoak and cleaner and experienced a reaction on their hands as a result. The employee sought medical treatment at a dermatology practice.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2018-00001 |
| MDR Report Key | 7429315 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-14 |
| Date Added to Maude | 2018-04-13 |
| 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. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| 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 | 0 |
| Brand Name | PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER |
| Generic Name | PRESOAK AND CLEANER |
| Product Code | FLG |
| Date Received | 2018-04-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-04-13 |