MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2014-12-15 for BIONECT CREAM manufactured by Fidia Farmaceutici Spa.
[17589456]
Ref imp#: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17703199]
As a result of a safety data reconciliation process between fidia and innocutis - the initial importer for the product in the usa, it was realized that this case, collected in 2012, had not been provided to fidia- product manufacturer - at the time due to an inexplicable oversight. As a result, in 2012 this case was reported to the agency by innocutis originally reported this case to the fda on 03/28/2012. As this report did not show in medwatch database, they resubmitted that in (b)(4) 2014. The quality assurance dept at fidia has performed a deep evaluation of the production and quality control documentation relative to the involved batch. This evaluation included a review of the production process, in-process controls, sterilization print-out, bioburden results, release results and the evaluation of the quality characteristics of the raw materials and components used in the manufacture of batch 016000. From this evaluation, no anomaly was found; the lot is considered in compliance with the specifications. No further info is expected for this case. This case is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610200-2014-00016 |
| MDR Report Key | 4390478 |
| Report Source | 04,08 |
| Date Received | 2014-12-15 |
| Date Mfgr Received | 2014-11-18 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2015-01-08 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GIUSEPPE DI SANTE, MD |
| Manufacturer Street | VIA PONTE DELLA FABBRICA 3/A |
| Manufacturer City | ABANO TERME, PADUA (PD) |
| Manufacturer Country | IT |
| Manufacturer Phone | 498232827 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIONECT CREAM |
| Generic Name | HYALURONIC ACID FOR TOPIC USE |
| Product Code | MGQ |
| Date Received | 2014-12-15 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FIDIA FARMACEUTICI SPA |
| Manufacturer Address | ABANO TERME, PADUA (PD) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-15 |