MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-22 for BIOZORB 3D BIOABSORBABLE MARKER F020-LOG590537 manufactured by Focal Therapeutics, A Hologic Company.
[176300347]
A (b)(6) y/o female had significant chronic pain and swelling in her left breast after her lumpectomy and sentinel node biopsy for breast cancer in (b)(6) 2018. Patient felt that she had allergic reaction to the biosorb device that was placed at the time of surgery, and had skin testing with shaved parts of pla. The skin testing was clearly positive. She requested to have the biosorb remove. During surgery, the biosorb was identify intact without any signs of incorporation by the body. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092435 |
| MDR Report Key | 9622123 |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-14 |
| Date Added to Maude | 2020-01-23 |
| 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 | 3 |
| Brand Name | BIOZORB 3D BIOABSORBABLE MARKER |
| Generic Name | MARKER RADIOGRAPHIC, IMPLANTABLE |
| Product Code | NEU |
| Date Received | 2020-01-22 |
| Model Number | F020-LOG590537 |
| Lot Number | A1-180606 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCAL THERAPEUTICS, A HOLOGIC COMPANY |
| Manufacturer Address | SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |