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 2020-01-31 for UP & UP UPC#017276234893 245070866 manufactured by Aso Llc.
[186371985]
The initial complaint by the customer did not indicate that an mdr would be required. However, per the info received on 01/03/2020 medical treatment was sought. Based on the information received, aso opted to file an mdr. As of 01/28/2020 no product was available for testing and no lot number was provided. Aso reviewed records of biocompatibility tests.
Patient Sequence No: 1, Text Type: N, H10
[186371986]
On the initial report on 12/06/2019 consumer reported the product caused reaction on her son's skin on cir received on 01/03/2020 consumer stated sought medical attention for her son.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2020-00005 |
| MDR Report Key | 9653358 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-03 |
| Date Mfgr Received | 2019-12-09 |
| Date Added to Maude | 2020-01-31 |
| 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 | UP & UP |
| Generic Name | HYDROGEL BURN PADS |
| Product Code | NAE |
| Date Received | 2020-01-31 |
| Model Number | UPC#017276234893 |
| Catalog Number | 245070866 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-31 |