MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-01-06 for PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER manufactured by Steris Corporation.
[64064440]
The employee sought medical treatment due to the reported event. A steris territory manager arrived onsite following the reported event. The territory manager observed user facility personnel use and handling of the prolystica 2x concentrate enzymatic presoak and cleaner and saw that the employees were not wearing proper ppe. Contrary to the steris territory managers observation, the facility's manager stated that the employee was wearing proper ppe during the time of the reported event. The steris territory manager observed that the gloves available for employee use did not reach above the wrists. The user facility's sterile processing manager implemented the use of 24 inch safety gloves and long sleeve gowns to be worn during use and handling of prolystica 2x concentrate enzymatic presoak and cleaner. The steris territory manager performed in-service training on the proper use and handling of prolystica 2x concentrate enzymatic presoak and cleaner and the importance of wearing proper ppe. The user facility confirmed that they have a copy of the prolystica 2x concentrate enzymatic presoak and cleaner safety data sheet (sds). The sds states: wear protective gloves/protective clothing/eye protection/face protection. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[64064441]
The user facility reported that an employee obtained a burn following use and handling of prolystica 2x concentrate enzymatic presoak and cleaner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2017-00001 |
| MDR Report Key | 6229231 |
| Report Source | USER FACILITY |
| Date Received | 2017-01-06 |
| Date of Report | 2017-01-06 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2017-01-06 |
| 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 | 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 AND CLEANER |
| Generic Name | PRESOAK AND CLEANER |
| Product Code | FLG |
| Date Received | 2017-01-06 |
| 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 | 2017-01-06 |