MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-23 for PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK & CLEANER manufactured by Steris Corporation.
[68211446]
The complainant sought and received medical treatment at the facility's emergency room department and returned to work. Additional personal protective equipment measures have been implemented by the user facility to prevent recurrence. The individual is still currently working with the prolystica 2x concentrate. The prolystica 2x concentrate enzymatic presoak and cleaner label states, "may cause allergy or asthma symptoms or breathing difficulties if inhaled. If inhaled: remove person to fresh air and keep comfortable for breathing". The safety data sheet states, "symptoms/injuries after inhalation: inhalation of vapors or spray/mists may cause allergy or asthma symptoms or breathing difficulties. May cause respiratory irritation". The safety data sheet also states, "precautions for safe handling: provide good ventilation in process area to prevent formation of vapor". No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[68211447]
The complainant reported shortness of breath after using the prolystica 2x concentrate enzymatic presoak and cleaner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2017-00004 |
| MDR Report Key | 6354585 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-23 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2017-02-23 |
| 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 | PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK & CLEANER |
| Generic Name | PRESOAK & CLEANER |
| Product Code | FLG |
| Date Received | 2017-02-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-02-23 |