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.
[4745542]
This spontaneous event was received by phone on (b)(6) 2013. Caller reports an adverse reaction to the product. Caller reports applying the cream yesterday morning. Caller reports that about 30 minutes after application, she experienced pain, a burning sensation, swelling, watering eyes and runny nose. Caller reports that she applied the product under her eyes near cheeks and inner eye. Caller reports she gently washed off the product right away with mild soap. Caller reports that symptoms have improved, but skin still has a burning sensation and there is still some redness. Caller reports that she was not on any other medications when used. Caller seemed distracted and slow to respond at times. It was explained that this is not an expected effect of using the product per label instructions. It was recommended that she discontinues use and wash exposed skin. Skin may be treated with cold compress and vitamin e oil and aloe vera cream. If any new or unexpected symptoms develop or the symptoms are not improving or resolving as discussed, please contact (b)(6) again 24/7 so that we might advise on further treatment or determine if referral to a healthcare professional might be needed. Caller was given the case number.
Patient Sequence No: 1, Text Type: D, B5
[12313796]
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 | 3005536974-2014-00003 |
| MDR Report Key | 4088184 |
| Report Source | 04 |
| Date Received | 2014-09-02 |
| Date of Report | 2014-08-13 |
| Date of Event | 2013-12-13 |
| Date Mfgr Received | 2013-12-14 |
| Device Manufacturer Date | 2012-11-01 |
| 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. SUITE 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 |
| Catalog Number | NA |
| Lot Number | 610336/3 |
| ID Number | 68712-007-02 |
| Device Expiration Date | 2014-11-01 |
| 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. SUITE 140 CHARLESTON SC 29401 US 29401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-02 |