MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-04 for OCUSOFT LID SCRUB manufactured by Ocusoft Inc..
[20919494]
First the slight burning of eye and surrounding tissue. Stopped using for 1 week. Second to 11th use no problems. Eleventh pre-moistened pad from packet 11 caused severe all night burning of all surrounding eye tissue, especially right under eye which hurt and peeled for 6 days. In my opinion, this product is unstable and is not uniformally formulated (it's not the same in all packets). I consider this product to be extremely dangerous and could possibly cause blindness. It should be taken off the market. When i called ocusoft inc. , they acted like i was looking for a refund. If this was the case, i could have returned product to the drug store. Dose or amount: pre-moistened pads. Frequency: dates of use: (b)(6) - (b)(6) 2010. Diagnosis or reason for use: cleansing of eye lids. Event abated after use: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017150 |
| MDR Report Key | 1812173 |
| Date Received | 2010-08-04 |
| Date of Report | 2010-07-23 |
| Date of Event | 2010-07-01 |
| Date Added to Maude | 2010-08-30 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OCUSOFT LID SCRUB |
| Generic Name | EYELID CLEANSER |
| Product Code | HOZ |
| Date Received | 2010-08-04 |
| Lot Number | 8138 |
| ID Number | 15718 10330 1 |
| Device Expiration Date | 2012-10-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OCUSOFT INC. |
| Manufacturer Address | P.O. BOX 429 RICHMOND TX 77406042 US 77406 0429 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-04 |