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 |