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 REXALL UPC#017276228175 00462701 manufactured by Aso Llc.
[183373827]
The initial complaint by the customer did not indicate that an mdr would be required. However, per the info received on 02/14/2020 medical treatment was required. Based on the information received, aso opted to file an mdr. As of 03/11/2020 unused returned product samples were submitted to the lab for testing with no defects noted. In addition, aso reviewed records of biocompatibility tests.
Patient Sequence No: 1, Text Type: N, H10
[183373828]
On the initial report on 01/06/2020 consumer reported the product tore her skin. On (b)(6) 2020 reporter stated on returned cir that the issue was with both tape and pad area and that she sought medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2020-00013 |
| MDR Report Key | 9831794 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-01-06 |
| 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 | REXALL |
| Generic Name | FABRIC BANDAGES ANTIBACTERIAL |
| Product Code | KGX |
| Date Received | 2020-03-13 |
| Model Number | UPC#017276228175 |
| Catalog Number | 00462701 |
| 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 |