MAUDE Adverse Event Report: INOPAK SANITYZE HAND SANITIZER; LIQUID HAND SANITYZER DISPENSER

Model Number JWGP

Device Problem Chemical Spillage (2894)

Patient Problem Eye Injury (1845)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

Hand sanitizer gel, sanityze got into a patients eyes as they pumped the sanityze gel liquid dispenser.The user followed up with an optometrist to flush her eyes.Report of chemical burn and cornea abrasion.The patient was given antibiotics and a patch for the eye.Saw ophthalmologist two days later and was given a steriod as well.Patient reports double vision, blurry vision and pain.The user said the incident occured on (b)(6) 2018.Crosstex ra/qa followed up with the user and it was reported they will be following up with an eye exam as they are still experiencing double vision.No product was returned for additional investigation.Crosstex followed up with the hand sanitizer gel manufacturer, inopak and they provided eye irritation testing.The labeling warnings state, "in case of eye contact, rinse immediately with water.Crosstex does not have any recent related complaints regarding eye injury from hand sanitizer.This complaint will continue to be monitored in crosstex complaint handling system.Hand sanityzer manufacturer information: (b)(4).

Event Description

It was reported that the customer pumped sanityze hand sanitizer and the gel got into her eyes.This required an optometrist to flush her eyes.It was reported that there was chemical burn and cornea abrasion.

• Brand Name: SANITYZE HAND SANITIZER
• Type of Device: LIQUID HAND SANITYZER DISPENSER
• Manufacturer (Section D): INOPAK; 24 executive parkway; ringwood NJ 07456
• Manufacturer (Section G): CROSSTEX INTERNATIONAL; 10 ranick rd; hauppauge NY 11788
• Manufacturer Contact: megan dickey ; 10 ranick rd; hauppauge, NY 11788 ; 7635533327
• MDR Report Key: 7400930
• MDR Text Key: 104528804
• Report Number: 2433773-2018-00001
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00732224002750
• UDI-Public: 0100732224002750
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: JWGP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other