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 2020-03-13 for TOPCARE UPC#036800402980 003680040298 manufactured by Aso Llc.
[185790919]
As of 03/11/2020 returned product and retained samples were submitted to the lab for testing with no defects noted. In addition, aso reviewed records of biocompatibility tests. Refer to section b. 6 of this report for further details.
Patient Sequence No: 1, Text Type: N, H10
[185790920]
On the initial report on 01/22/2020 consumer reported the bandages tore his skin. On 02/14/2020 consumer stated on returned cir that he treated himself (consumer is a physician).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2020-00012 |
| MDR Report Key | 9831611 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-07-17 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Manufacturer Country | US |
| Manufacturer G1 | ASO LLC |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA, FL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOPCARE |
| Generic Name | FABRIC ADHESIVE BANDAGES ANTIBACTERIAL |
| Product Code | KGX |
| Date Received | 2020-03-13 |
| Model Number | UPC#036800402980 |
| Catalog Number | 003680040298 |
| Lot Number | 00110016 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-13 |