MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-26 for PROLYSTICA HP NEUTRAL MANUAL CLEANER manufactured by Steris Corporation.
[122164762]
The lot history record (lhr) for prolystica hp manual cleaner was reviewed and no abnormalities were noted. The manual cleaner's safety data sheet states (page 4; section 11)," toxicological information, symptoms/injuries after skin contact may cause irritation". Prolystica hp neutral manual cleaner is non-toxic and not considered hazardous. A steris account manager stated that the customer is a new user of prolystica hp manual cleaner. The customer has decided to replace the manual cleaner with a new steris detergent. This is the first complaint of irritation ever received by steris for the product subject of the event and no additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[122164763]
The user facility reported that employees experienced light throat irritation while handling prolystica hp neutral manual cleaner. No medical treatment was sought or administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1937531-2018-00002 |
| MDR Report Key | 7911955 |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-08-29 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-09-26 |
| 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 | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| 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 HP NEUTRAL MANUAL CLEANER |
| Generic Name | CLEANER |
| Product Code | FLG |
| Date Received | 2018-09-26 |
| Lot Number | 294085 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-09-26 |