MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA HP NEUTRAL MANUAL CLEANER

Lot Number 294085

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Irritation (1941)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The user facility reported that employees experienced light throat irritation while handling prolystica hp neutral manual cleaner.No medical treatment was sought or administered.

• Brand Name: PROLYSTICA HP NEUTRAL MANUAL CLEANER
• Type of Device: CLEANER
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer (Section G): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7911955
• MDR Text Key: 122164762
• Report Number: 1937531-2018-00002
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 294085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1