MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-19 for PROLYSTICA 2X CONCENTRATE NEUTRAL DETERGENT manufactured by Steris Corporation.
[57916418]
The user facility stated that prior to the reported event, the instruments were soaked with prolystica 2x concentrate neutral detergent. Following the reported event, a steris consumable manager arrived onsite and performed in-service training on the proper use and handling of prolystica 2x concentrate neutral detergent, specifically the correct method for product dilution, rinsing of instruments after soaking, and visual inspection of instruments after rinsing. The prolystica 2x concentrate neutral detergent product label states: "fill sink or basin with warm water to the appropriate level to fully immerse surgical instruments. Dilute chemistry at 1/8 to 1/2 fl. Oz. Per gallon of warm water depending on water quality and soil load. Soak for a minimum of 1-5 minutes. " "all surfaces should be thoroughly rinsed with warm water. Solutions should be discarded daily or when visibly soiled. "
Patient Sequence No: 1, Text Type: N, H10
[57916419]
The user facility reported that two patients experienced eye irritation following a procedure. The patients were prescribed steroid eye drops.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2016-00002 |
| MDR Report Key | 6042590 |
| Date Received | 2016-10-19 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-09-16 |
| Date Mfgr Received | 2016-09-19 |
| Date Added to Maude | 2016-10-19 |
| 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 | 0 |
| Brand Name | PROLYSTICA 2X CONCENTRATE NEUTRAL DETERGENT |
| Generic Name | NEUTRAL DETERGENT |
| Product Code | FLG |
| Date Received | 2016-10-19 |
| Lot Number | 280873 |
| 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 | 2016-10-19 |