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 2020-02-07 for DG HEALTH UPC#017276234824 22247001 manufactured by Aso Llc.
[188672205]
As of 01/30/2020 returned product and retained samples were submitted to the lab for testing with no defects noted. In addition, aso reviewed records of biocompatibility tests. Refer to section b. 6 of this report for further details.
Patient Sequence No: 1, Text Type: N, H10
[188672206]
Consumer stated that product created a burn on her skin when applied after a surgery. Consumer stated that medical attention was sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038758-2020-00006 |
| MDR Report Key | 9683349 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-11-20 |
| Date Added to Maude | 2020-02-07 |
| 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 34240 |
| Manufacturer Country | US |
| Manufacturer Postal | 34240 |
| Manufacturer G1 | ASO LLC |
| Manufacturer Street | 300 SARASOTA CENTER BLVD. |
| Manufacturer City | SARASOTA FL 34240 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34240 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DG HEALTH |
| Generic Name | SHEER ADHESIVE PADS |
| Product Code | KGX |
| Date Received | 2020-02-07 |
| Model Number | UPC#017276234824 |
| Catalog Number | 22247001 |
| Lot Number | 00117493 |
| 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 34240 US 34240 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |