MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ARJO FLUSHER DETERGENT; WASHER OF BODY WASTE RECEPTACLES

Device Problem Use of Device Problem (1670)

Patient Problem Sore Throat (2396)

Event Date 10/10/2023

Event Type  Injury  

Event Description

Arjo was informed of an event involving arjo liquid flusher rinse and arjo liquid flusher detergent used with some other liquids (i.E.Clements chemicals - non arjo products) to clean the waste transfer station area.After washing the floor, the waste transfer station was closed overnight (without ventilation) and opened early in the morning by transport workers.Transport workers complained about sore eyes/throat.Additional information was received that some workers were given eye drops and ointment.Some of them required another visit to the eye clinic and some required care in the hospital.

• Brand Name: ARJO FLUSHER DETERGENT
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• MDR Report Key: 18265736
• MDR Text Key: 329719214
• Report Number: 1419652-2023-00060
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2023
• Distributor Facility Aware Date: 11/06/2023
• Event Location: Other
• Date Report to Manufacturer: 12/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization