MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-12-15 for BIONECT CREAM manufactured by Fidia Farmaceutici Spa,.
[5365120]
This spontaneous report was received from a consumer via phone on (b)(6) 2012. The consumer reports she started using the product on friday, (b)(6) 2012, applying it to her vulva twice daily for a vaginal cut. About 8 hours after the first dose, she broke out into hives and also developed chest pain, back pain, and wheezing. She continued to use the product on (b)(6) 2012. In the middle of the night on (b)(6) 2012 she decided to go to the local emergency room. While in the emergency room she received an albuterol nebulizer. She is currently on prednisone and an unk antihistamine which was prescribed by the emergency room physician. The hives have not healed completely, but her other symptoms have dissipated. Mfr ref# 9610200-2014-00016.
Patient Sequence No: 1, Text Type: D, B5
[12689178]
The info contained in this report is based on self-reported statements provided to the manufacturer during a telephone interview. These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, info contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related or associated with an exposure to the product identified in the telephone interview. The info provided in this report has not been medically verified via confirmation with the patient's physicians or by the provision of patient medical records. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on topically applied hyaluronate containing product such a causal relationship between the use of this type of device and the development of the adverse effects reported in this case cannot be definitively established. When evaluating a patient for a potential hypersensitivity (allergic) reaction, a clinical practitioner must consider several potential environmental etiologies as well as any foods, beverages, medications, or dietary supplements the patient had been taking just prior to the onset of symptoms. Definitive causality cannot be applied to any one compound or agent without verification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005536974-2012-00002 |
| MDR Report Key | 4387818 |
| Report Source | 99 |
| Date Received | 2014-12-15 |
| Date of Report | 2012-02-02 |
| Date of Event | 2012-01-27 |
| Date Facility Aware | 2011-12-20 |
| Report Date | 2014-11-18 |
| Date Reported to FDA | 2012-02-08 |
| Date Reported to Mfgr | 2014-11-18 |
| Date Added to Maude | 2015-01-08 |
| Event Key | 0 |
| Report Source Code | Distributor 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 |
| Manufacturer Street | 140 E BAY STREET SUITE C |
| Manufacturer City | CHARLESTON SC 29401 |
| Manufacturer Country | US |
| Manufacturer Postal | 29401 |
| Manufacturer G1 | JSJ PHARMACEUTICALS |
| Manufacturer Street | 140 E BAY STREET SUITE C |
| Manufacturer City | CHARLESTON SC 29401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIONECT CREAM |
| Generic Name | HYALURONIC ACID SODIUM SALT |
| Product Code | MGQ |
| Date Received | 2014-12-15 |
| Lot Number | 016000 |
| ID Number | 68712-008-03 |
| Device Expiration Date | 2012-11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FIDIA FARMACEUTICI SPA, |
| Manufacturer Address | VIA PONTE DELLA FABBRICA 3/A ABANO TERME (PD) 35031 IT 35031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-15 |