MAUDE Adverse Event Report: METREX RESEARCH CAVIWIPES XL 12/CS; SURFACE DISINFECTANT

Catalog Number 13-1150

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

Patient Problem Swelling (2091)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

No patient information was provided in regards to ethnicity and race.No information was provided in regards to lot number, therefore device manufacturing date could not be determined.The product involved in the alleged incident was not returned and no lot number was provided; therefore no further evaluation could be done.

Event Description

A complainant alleged that while using caviwipes the liquid from one of the tissues was flung into her eye when removing from the container.The complainant rinsed her eye after exposure.Eye became red and swollen.Complainant visited an eye doctor who noted an abrasion and was given a contact lens as well as eye drops.Redness and swelling has subsided, but complainant still has sensitivity to light.

• Brand Name: CAVIWIPES XL 12/CS
• 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: paulo calle ; 1717 w collins avenue; orange, CA 92867 ; 7145167752
• MDR Report Key: 7774122
• MDR Text Key: 116807933
• Report Number: 1722021-2018-00003
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 13-1150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2018
• 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
• Patient Age: 31 YR
• Patient Weight: 115