MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-06 for PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER manufactured by Steris Corporation.
[19065450]
A steris account manager arrived onsite and found personnel to be using the product in a temporary work space. The account manager performed in-service training on dosing and proper use of the product in the temporary work space as personnel do not have access to an acu-sink in this room. In addition, the account manager discussed the importance of proper ppe. Personnel who handle prolystica stated they their arms get wet while cleaning. Cleaning with this product is performed by a third party reprocessing company that works on-site. The user facility stated that they are unable to provide additional investigation information specifically whether medical treatment was sought or administered. The user facility stated they will contact the third party reprocessing company in regards to the reported event. The prolystica product label states: "warning- irritating to eyes and skin. Prolonged or frequently repeated contact to subtilisins may cause allergic reaction in some individuals. " "do not get in eyes, on skin or on clothing. Wear protective eyewear and gloves. "
Patient Sequence No: 1, Text Type: N, H10
[19092567]
The user facility reported that staff members are developing rashes after contact with prolystica.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2015-00003 |
| MDR Report Key | 4576465 |
| Report Source | 06 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-03-06 |
| Date of Event | 2015-02-06 |
| Date Mfgr Received | 2015-02-06 |
| Date Added to Maude | 2015-03-06 |
| 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 | PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER |
| Generic Name | CLEANER |
| Product Code | FLG |
| Date Received | 2015-03-06 |
| 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 | 2015-03-06 |