MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-03-25 for CAREONE UPC041520060969 048905995 manufactured by Aso Llc.
[139804339]
Customer returned product and retains from the same lot were evaluated for adhesion strength and defects with no issues reported. As of 03/25/2019 the customer has not provided additional information. In addition, aso reviewed records of biocompatibility tests of similar product with no issues found.
Patient Sequence No: 1, Text Type: N, H10
[139804340]
Daughter used one and woke up with a bruised nose and two black eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2019-00011 |
| MDR Report Key | 8450186 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-03-25 |
| Date of Report | 2019-02-23 |
| Date of Event | 2019-02-23 |
| Date Mfgr Received | 2019-02-23 |
| Device Manufacturer Date | 2018-08-28 |
| Date Added to Maude | 2019-03-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FEDERICO JULIAO |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer G1 | ASO LLC |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREONE |
| Generic Name | NASAL DILATORS |
| Product Code | LWF |
| Date Received | 2019-03-25 |
| Model Number | UPC041520060969 |
| Catalog Number | 048905995 |
| Lot Number | 00091176 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASO LLC |
| Manufacturer Address | 300 SARASOTA CENTER BLVD. SARASOTA FL 34240 US 34240 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-25 |