MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-02 for MICROPEN manufactured by Unk.
[81916937]
Caller underwent this procedure a month ago. Her skin was destroyed by apparatus. Leaving her with permanent lines. The reason for this procedure is to repair a "place" that was left behind after a chemical peel to remedy fine wrinkles especially around her eyes. She says the top layers of skin were shredded changing the pigmentation and leaving embedded lines. Face is now damaged and scarred. She's seen and esthetician, dermatologist, and a plastic surgeon. The micro needling was done at dr (b)(6)'s office in (b)(6). Collagen micropen micro needling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071377 |
| MDR Report Key | 6767275 |
| Date Received | 2017-08-02 |
| Date of Report | 2017-07-12 |
| Date Added to Maude | 2017-08-04 |
| 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 |
| 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 | MICROPEN |
| Generic Name | SKIN PEN |
| Product Code | GFE |
| Date Received | 2017-08-02 |
| Device Availability | * |
| 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 | 2017-08-02 |