MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-11 for WALGREENS UPC#311917195254 884646 manufactured by Aso Llc.
[185990455]
As of 03/11/2020 returned product and retained samples of the same lot of the reported device 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
[185990456]
On the initial report on (b)(6) 2020 consumer reported the bandages caused her skin rash. She stated sought medical treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2020-00011 |
| MDR Report Key | 9820963 |
| Report Source | CONSUMER |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2018-05-25 |
| Date Added to Maude | 2020-03-11 |
| 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 | WALGREENS |
| Generic Name | PERFORMANCE FABRIC BANDAGES |
| Product Code | KGX |
| Date Received | 2020-03-11 |
| Model Number | UPC#311917195254 |
| Catalog Number | 884646 |
| Lot Number | 00085867 |
| 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 | 2020-03-11 |