MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-14 for LIPIFLOW manufactured by Unk.
[100309619]
Within days of having the procedure using the medical device known as lipiflow performed on both my eyes. I developed the following symptoms and conditions: constant tearing, stinging and burning sensation, swollen eyes lids, conjunctivitis, and worsening visual acuity. I had subsequently had to be treated with a myriad of drugs, including lotemax and prednisolone eye drops, etc. My eye doctor, dr. (b)(6), (b)(6), has had to examine me twice since he performed the lipiflow procedure. I am presently scheduled to see him again for the third time later this morning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075277 |
| MDR Report Key | 7273444 |
| Date Received | 2018-02-14 |
| Date of Report | 2018-02-12 |
| Date of Event | 2018-01-31 |
| Date Added to Maude | 2018-02-15 |
| 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 | LIPIFLOW |
| Generic Name | EYELID THERMAL PULSATION SYSTEM |
| Product Code | ORZ |
| Date Received | 2018-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 2018-02-14 |