MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-19 for SUPERNOVA SSL-20 manufactured by Vyaire Medical.
[142533221]
At this time, vyaire has not received the suspect device for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[142533222]
The customer reported that the patient developed bruising around left eye post surgical procedure. The supernova mask was placed and operated without incident. The mask was discontinued after 30 minutes of use due to an unrelated surgical complication requiring general anesthesia. The cardiovascular surgeon explained that the patient developed bruising around the left eye due to utilization of the supernova mask. Additional request for clarification revealed that the mask was applied according to manufacturer's guidelines. The larger blue mask was sized appropriately according to the characteristics of the patient's nose. Afterwards, the patient stated that he bruises easily with activity. No medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-2019-00026 |
| MDR Report Key | 8532845 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-19 |
| Date of Report | 2019-02-08 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2019-04-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | SUNMED, LLC |
| Manufacturer Street | 2710 NORTHRIDGE DR NW STE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERNOVA |
| Generic Name | RESUSCITATION KITS |
| Product Code | NHK |
| Date Received | 2019-04-19 |
| Model Number | SSL-20 |
| Catalog Number | SSL-20 |
| Lot Number | 316818 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-19 |