MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for DUROLANE 60 manufactured by Bioventus, Llc..
[181220142]
One month after left knee durolane injection, patient developed skin rash deemed to be caused by skin embolus from hyaluronic acid crystals. Lot: 16928, dose amount: 60 mg, frequency: prn, route: intra-articular, start: (b)(6) 2019, stop: (b)(6) 2019. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093268 |
| MDR Report Key | 9753329 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-22 |
| Date of Event | 2019-12-06 |
| Date Added to Maude | 2020-02-26 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUROLANE 60 |
| Generic Name | ACID, HYALURONIC, INTRAARTICULAR |
| Product Code | MOZ |
| Date Received | 2020-02-25 |
| Lot Number | 16928 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOVENTUS, LLC. |
| Product Code | --- |
| Date Received | 2020-02-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-25 |