MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for SANITYZE HAND SANITIZER JWGP manufactured by Inopak.
[104528804]
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).
Patient Sequence No: 1, Text Type: N, H10
[104528805]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433773-2018-00001 |
| MDR Report Key | 7400930 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-03-06 |
| Date Added to Maude | 2018-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEGAN DICKEY |
| Manufacturer Street | 10 RANICK RD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer Phone | 7635533327 |
| Manufacturer G1 | CROSSTEX INTERNATIONAL |
| Manufacturer Street | 10 RANICK RD |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11788 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SANITYZE HAND SANITIZER |
| Generic Name | LIQUID HAND SANITYZER DISPENSER |
| Product Code | LRJ |
| Date Received | 2018-04-05 |
| Model Number | JWGP |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INOPAK |
| Manufacturer Address | 24 EXECUTIVE PARKWAY RINGWOOD NJ 07456 US 07456 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-05 |