MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for DUROLANE manufactured by Bioventus Llc.
[181629507]
Pt called to report an adverse event involving her durolane injection in her left knee. Pt stated that when she received the injection 6 weeks ago, the physician, dr (b)(6), hit the bone. The pt said it was very painful and 2 weeks later her left knee became very swollen and infected. The pt said the infection went away after two weeks. The pt stated she was charged (b)(6) for the injection, which she felt was an overcharge. Pt stated she is experiencing continuing pain in the back of her leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093310 |
| MDR Report Key | 9763544 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-01 |
| Date Added to Maude | 2020-02-27 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUROLANE |
| Generic Name | ACID, HYALURONIC, INTRAARTICULAR |
| Product Code | MOZ |
| Date Received | 2020-02-26 |
| Lot Number | 89130-2020-1 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOVENTUS LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-26 |