MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-19 for BIOPALYMER UNK manufactured by Biocell Labs.
[261208]
Product was injected to treat laugh lines and wrinkles. The pt is now experiencing swelling because the product is moving around. Pt is having trouble finding someone to explant the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026023 |
| MDR Report Key | 414088 |
| Date Received | 2002-08-19 |
| Date of Report | 2002-08-19 |
| Date of Event | 1999-11-01 |
| Date Added to Maude | 2002-09-04 |
| 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 | 0 |
| 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 | BIOPALYMER |
| Generic Name | * |
| Product Code | KGM |
| Date Received | 2002-08-19 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 403127 |
| Manufacturer | BIOCELL LABS |
| Manufacturer Address | * VADUZ LIECHTENSTEIN SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-08-19 |