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 2020-02-21 for EQUATE UPC#681131006712 566928030 manufactured by Aso Llc.
[188552445]
As of 02/14/2020 aso has not received returned product or lot number information from the consumer for further investigation. Satisfactory biocompatibility test results and latex screenings for the materials used to manufacture the same type of products were reviewed. Refer to b. 6 for further details.
Patient Sequence No: 1, Text Type: N, H10
[188552446]
On the initial report on 01/23/2020 consumer stated the bandages caused her an allergic reaction. Consumer added sought medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2020-00009 |
| MDR Report Key | 9741622 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-11-19 |
| Date Added to Maude | 2020-02-21 |
| 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 | EQUATE |
| Generic Name | FLEXIBLE FABRIC BANDAGES ANTIBACTERIAL |
| Product Code | KGX |
| Date Received | 2020-02-21 |
| Model Number | UPC#681131006712 |
| Catalog Number | 566928030 |
| Lot Number | 00117018 |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-21 |