MAUDE Adverse Event Report: METREX RESEARCH BENCO Z3 SURFACE DISINFECTANT

Catalog Number 13-7900

Device Problem Chemical Spillage (2894)

Patient Problems Irritation (1941); Burning Sensation (2146); Reaction (2414)

Event Date 03/06/2014

Event Type  Injury  

Event Description

A complainant alleged that benco z3 surface disinfectant had splashed into her eye while refilling a spray bottle and she had experienced a reaction with symptoms of burning and irritation.

Manufacturer Narrative

The employee sought further medical attention from an ophthalmologist and an eye exam was performed.The employee was diagnosed with eye irritation due to ammonium chloride.Eye drops were prescribed for treatment of the symptoms.It was confirmed on (b)(6) 2014 that the employee had fully recovered.To date, the employee is doing fine.The product involved in the alleged incident was not returned; therefore, a visual and physical evaluation was performed on a retained sample, yielding results within specifications.In addition, no similar complaints were received with regard to this lot.

• Brand Name: BENCO Z3 SURFACE DISINFECTANT
• Type of Device: SURFACE DISINFECTANT
• Manufacturer (Section D): METREX RESEARCH; 28210 wick road; romulus MI 48174
• Manufacturer (Section G): METREX RESEARCH; 28210 wick road; romulus MI 48174
• Manufacturer Contact: kerri casino ; 1717 west collins avenue; orange, CA 92867 ; 7145167634
• MDR Report Key: 3706268
• MDR Text Key: 4334249
• Report Number: 1722021-2014-00007
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Expiration Date: 09/01/2015
• Device Catalogue Number: 13-7900
• Device Lot Number: 13-2254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 60