MAUDE Adverse Event Report: METREX RESEARCH CAVICIDE GALLONS 4/CS; SURFACE DISINFECTANT

Catalog Number 13-1000

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burn(s) (1757)

Event Date 03/20/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that user had to seek medical intervention and was prescribed steroid cream.End-user stated he was doing better, but would take time to heal.No information was provided in regards to weight, age, 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 they took gloves off and had chemical burns all over their hands additional symptoms included peeling skin, bumps all over hands and finger.

• Brand Name: CAVICIDE GALLONS 4/CS
• Type of Device: SURFACE DISINFECTANT
• Manufacturer (Section D): METREX RESEARCH; 28210 wick road; romulus, mi
• Manufacturer (Section G): METREX RESEARCH; 28210 wick road; romulus, mi
• Manufacturer Contact: paulo calle ; 1717 w collins avenue; orange, ca ; 5167752
• MDR Report Key: 9946944
• MDR Text Key: 189460137
• Report Number: 1722021-2020-00001
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 13-1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• 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