MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-09-02 for BIONECT CREAM, 25G TUBE manufactured by Innocutis.
[4746026]
This spontaneous report was received from a consumer via phone on (b)(6) 2013. The consumer reports that he has a dry skin condition on his scalp and that a dermatologist advised him to use the product. He finds that when he uses the product, his scalp becomes very red. He contacted the dermatologist, who advised him to keep using the product, and that the redness "should calm down. " caller wishes to know if this is advisable, as the redness seems to progressively worsen. It was explained to the caller that increased redness and soreness are not expected effects with product use. It was recommended that he discontinue use of the product, and consult with his dermatologist about the symptoms he is having, and request further guidance from the doctor.
Patient Sequence No: 1, Text Type: D, B5
[12314661]
The information 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, information contained in this report does not and can not form the basis for a determination of whether the report clinical effects are causally related or associated with an exposure to the product identified in the telephone interview. The information 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 wright 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 goods, 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 | 3005536974-2014-00002 |
| MDR Report Key | 4088166 |
| Report Source | 04 |
| Date Received | 2014-09-02 |
| Date of Report | 2014-08-13 |
| Date of Event | 2013-01-29 |
| Date Mfgr Received | 2013-01-29 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2014-09-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ART WAITE |
| Manufacturer Street | 171 CHURCH ST. STE 140 |
| Manufacturer City | CHARLESTON SC 29401 |
| Manufacturer Country | US |
| Manufacturer Postal | 29401 |
| Manufacturer Phone | 8439658333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIONECT CREAM, 25G TUBE |
| Generic Name | HYALURONATE SODIUM |
| Product Code | MGQ |
| Date Received | 2014-09-02 |
| Model Number | NA |
| Lot Number | 0164 |
| ID Number | 68712-007-02 |
| Device Expiration Date | 2013-11-01 |
| 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 | INNOCUTIS |
| Manufacturer Address | 171 CHURCH ST. STE 140 CHARLESTON SC 29401 US 29401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-02 |