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 2020-03-06 for EQUATE UPC#681131006736 566928026 manufactured by Aso Llc.
[182472886]
The initial complaint by the customer did not indicate that an mdr would be required. However, per the info received on (b)(6) 2020 consumer stated medical treatment was sought. Based on the information received, aso opted to file an mdr. As of 03/05/2020 unused retained samples of the same lot as the product reported and returned product were submitted to the lab for testing with no defects noted. In addition, aso reviewed records of biocompatibility tests with no issues noted. Refer to this report for further details.
Patient Sequence No: 1, Text Type: N, H10
[182472887]
On the initial report of 01/15/2020 consumer stated that the adhesive part of the product caused him red mark and irritation on his abdominal skin. On email received on (b)(6) 2020 consumer stated sought medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2020-00010 |
| MDR Report Key | 9802295 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-08 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-10-31 |
| Date Added to Maude | 2020-03-06 |
| 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 | HEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL |
| Product Code | KGX |
| Date Received | 2020-03-06 |
| Model Number | UPC#681131006736 |
| Catalog Number | 566928026 |
| Lot Number | 00116601 |
| 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 | 2020-03-06 |