MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-27 for PROLYSTICA 2X ENZYMATIC PRESOAK AND CLEANER manufactured by Steris Corporation.
[5880530]
The user facility reported that a patient suffered eye exposure to prolystica 2x enzymatic presoak and cleaner.
Patient Sequence No: 1, Text Type: D, B5
[13341466]
The user facility contacted (b)(6) for advice and medical assistance. (b)(6) contacted the (b)(6) poison and drug center for immediate medical assistance. The prolystica 2x concentrate enzymatic presoak and cleaner label clearly states, "warning: contains subtilisins (proteolytic enzyme)((b)(4)). Irritating to eyes and skin. Prolonged or frequently repeated contact to subtilisins may cause allergic reaction in some individuals... Wear protective eyewear and gloves. " steris made multiple attempts to obtain additional information, however the user facility will not respond.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1937531-2015-00004 |
| MDR Report Key | 4799369 |
| Report Source | 06 |
| Date Received | 2015-05-27 |
| Date of Report | 2015-05-27 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-05-01 |
| Date Added to Maude | 2015-05-27 |
| 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 | 2015-05-27 |
| 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 | 2015-05-27 |