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 CVS HEALTH UPC#050428269756 865378 manufactured by Aso Llc.
[183373777]
As of 03/12/2020 aso evaluated returned product and retained samples with no defects noted. In addition, aso reviewed records of biocompatibility tests.
Patient Sequence No: 1, Text Type: N, H10
[183373778]
On the initial report on (b)(6) 2020 consumer states that the product caused him an allergic reaction. Medical attention was sought. On (b)(6) 2020 reporter stated on returned cir that issue was with tape area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2020-00014 |
| MDR Report Key | 9831875 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-11-06 |
| 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 | CVS HEALTH |
| Generic Name | FLEXIBLE FABRIC ANTIBACTERIAL BANDAGES |
| Product Code | KGX |
| Date Received | 2020-03-13 |
| Model Number | UPC#050428269756 |
| Catalog Number | 865378 |
| Lot Number | 00116613 |
| 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 |