MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-11 for * manufactured by *.
[17374315]
2003 - had permanent cosmetic applied to their eyebrows. 2004 - went back for a touch up (larger) of eyebrows. 2004 - started getting small bumps on brows. 2004 - to pres; still have problems with eyebrows, now raised eyebrows, with bump on right brow towards the nose, brows dry out and itchy at all times with flaking. Signed up for a dermatologist study prg 2004 for tattooing. Visit was made to the dr and was given medication which did not help the problem. Contact was made with the organization that did the tattooing. Made suggestions on creams to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032057 |
| MDR Report Key | 527109 |
| Date Received | 2004-05-11 |
| Date Added to Maude | 2004-06-01 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | PERMANENT COSMETIC |
| Product Code | HSP |
| Date Received | 2004-05-11 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 516277 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2004-05-11 |