MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-04-09 for NONE manufactured by .
[2639751]
The following email was received from (b)(6) on (b)(6) 2011 and forwarded for documentation and f/u on (b)(4) 2011. "i have a question about using bionect off-label. I used to inject into a deep fold in my chin area. I normally have restylane put there. I used a small gauge needle like one that would be used with restylane. It did fill in the fold and looks very normal. Have i done any permanent damage since this is supposed to be a topical only drug? I am afraid to ask my dermatologist because i know that they just want to sell me another round of fillers, restylane, juverderm, etc... At a time that i cannot afford it. The last time the restylane did not even last nine months. Thank you for your assistance. " an email was sent to the consumer requesting that she contact our 24/7 drug safety call center for further info. We have not heard from the consumer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005536974-2012-00001 |
| MDR Report Key | 2586463 |
| Report Source | 04 |
| Date Received | 2012-04-09 |
| Date of Report | 2011-12-20 |
| Date Mfgr Received | 2011-12-20 |
| Date Added to Maude | 2012-05-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ART WAITE |
| Manufacturer Street | 171 CHURCH ST SUITE 140 |
| Manufacturer City | CHARLESTON SC 29401 |
| Manufacturer Country | US |
| Manufacturer Postal | 29401 |
| Manufacturer Phone | 8439658333 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | MGQ |
| Date Received | 2012-04-09 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-09 |