MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for OTC OCUFOFT LID SCRUB manufactured by Ocusoft Inc..
[144551117]
Ophthalmologist recommended original otc ocusoft lid wipes to clean lids to treat asymptomatic blepharitis. After two uses as directed i developed a severe adverse reaction. Lids became swollen, red, and itchy. Since reaction, eyelids are now permanently sensitized to cleaning. I can no longer tolerate any cleaning of the eyelids without having a reaction such as pain and swelling. Since use my blepharitis is now chronic and symptomatic along with severe chronic dry eye. Minor triggers, such as touching, heat, wind or reading, now causes an adverse reaction, such as irritation, redness, and lid swelling. Frequency: twice to clean lid. How was it taken or used: topical. Date the person first started taking or using the product: (b)(6) 2017; date the person stopped taking or using the product: (b)(6) 2017. Reason for use: to clean eyelid margins.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086457 |
| MDR Report Key | 8591326 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-04 |
| Date of Event | 2017-12-09 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OTC OCUFOFT LID SCRUB |
| Generic Name | SPONGE, OPHTHALMIC |
| Product Code | HOZ |
| Date Received | 2019-05-07 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OCUSOFT INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-05-07 |