MAUDE Adverse Event Report: MEDIVATORS INTERCEPT DETERGENT; ENDOSCOPE DETERGENT

Catalog Number ML02-0106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chemical Exposure (2570)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

A facility reported that an employee was exposed to intercept detergent by splashing it in his eye.The affected personnel rinsed his eye for 15 minutes and then went to the employee health service office.The reporter from the facility received the safety data sheet for treatment instructions.Medivators regulatory affairs has made multiple attempts to contact the initial reporter with no success.It is unknown if appropriate ppe was worn when the incident occurred.This complaint will continue to be monitored in medivators complaint system.

Event Description

Facility reported an employee had chemical exposure of intercept detergent to their eye.It was reported that the employee rinsed his eye for 15 minutes and sds was sent to facility.

• Brand Name: INTERCEPT DETERGENT
• Type of Device: ENDOSCOPE DETERGENT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 6603352
• MDR Text Key: 76372100
• Report Number: 2150060-2017-00029
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964043086
• UDI-Public: 00677964043086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: ML02-0106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other