MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-09-28 for SKIMATIX ULTRA manufactured by Bausch + Lomb.
[122090197]
Investigation of this event is in progress. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[122090198]
It was reported that a patient experienced itching, swelling, redness, and the appearance of dots in the lower eyelids one day after use of the product. The patient was prescribed the product by a dermatologist in order to treat erythema in the lower eyelids following a cosmetic laser procedure 13 days prior. As a result of the adverse reaction, the patient went to the emergency room for treatment. The following day, the patient returned to her dermatologist and was prescribed additional medication to apply topically to the affected areas. The patient's swelling has resolved, but the remaining symptoms are said to remain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009443653-2018-00019 |
| MDR Report Key | 7919484 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-03 |
| Date of Event | 2018-08-31 |
| Date Added to Maude | 2018-09-28 |
| 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 | MS. TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | HANSON MEDICAL |
| Manufacturer City | KINGSTON WA 98346 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98346 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKIMATIX ULTRA |
| Product Code | MDA |
| Date Received | 2018-09-28 |
| Model Number | SKIMATIX ULTRA |
| Lot Number | 9014855 |
| Device Expiration Date | 2018-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-28 |