MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA; CLEANER

Device Problems Use of Device Problem (1670); Chemical Spillage (2894)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

The complainant declined to provide the injured individual contact information or product information to steris.Steris instructed the complainant to have the user follow the safety data sheet (sds) for the product.Due to the complainants refusal to provide contact or product information, steris is unable to obtain additional details; specifically, if the user sought or received medical treatment.We have been unable to obtain additional information regarding the reported event and therefore filing this report as we cannot determine if the event meets the reporting criteria outlined in 21 cfr 803.A follow-up report will be filed should we receive additional information.

Event Description

A complainant contacted steris stating an individual spilled prolystica on themselves and obtained burns.

• Brand Name: PROLYSTICA
• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6407726
• MDR Text Key: 70315752
• Report Number: 1937531-2017-00005
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• 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: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2017
• 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
• Patient Outcome(s): Other