MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-08 for PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER manufactured by Steris Corporation.
[6022699]
The user facility reported two employees experienced a headache and watering eyes while using prolystica 2x enzymatic presoak and cleaner. The employees subject of the reported event did not seek medical treatment.
Patient Sequence No: 1, Text Type: D, B5
[14226920]
The user facility confirmed the employees were wearing appropriate ppe and air exchanges within the room were adequate. Both employees returned to work and were reassigned to a different area. The instructions for use and label for prolystica 2x enzymatic presoak and cleaner state, "warning: irritating to eyes and skin. Prolonged or frequently repeated contact to subtilisins [found within this product] may cause allergic reactions in some individuals. " no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1937531-2015-00007 |
| MDR Report Key | 4899440 |
| Report Source | 06 |
| Date Received | 2015-07-08 |
| Date of Report | 2015-07-08 |
| Date Mfgr Received | 2015-06-12 |
| Date Added to Maude | 2015-07-08 |
| 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 | 2015-07-08 |
| 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 | 2015-07-08 |