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.
[5429690]
Ref imp#: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12750959]
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. No batch number was received on this complaint; therefore, no investigation can be conducted. Conclusion: no investigation/ no assessment possible. No further info is expected for this case. Case status: closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610200-2014-00017 |
| MDR Report Key | 4390475 |
| Report Source | 04,08 |
| Date Received | 2014-12-15 |
| Date Mfgr Received | 2014-11-18 |
| 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 SI SANTE, MD |
| Manufacturer Street | VIA PONTE DELLA FABBRICA 3/A |
| Manufacturer City | ABANO TERME, PADUA (PD) 35031 |
| Manufacturer Country | IT |
| Manufacturer Postal | 35031 |
| 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 |
| Product Code | MGQ |
| Date Received | 2014-12-15 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |