FDA Adverse Event
Injury
Summary report: N
AMAZON BASIC+CARE
MDR report key: 23198512
·
Received October 2, 2025
Report
- Report Number
- 1038758-2025-00024
- Event Type
- Injury
- Date Received
- October 2, 2025
- Date of Event
- September 5, 2025
- Report Date
- October 2, 2025
- Manufacturer
- EUROMED, INC.
- Product Code
- NAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
AS (B)(6) 2025 THE MANUFACTURER HAS COMPLETED THEIR INVESTIGATION WITH NO ISSUES FOUND. ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS WITH NO ISSUES NOTED. REFER TO SECTION B.6 OF THIS REPORT FOR FURTHER DETAILS.
Description of Event or Problem · 0
ACCORDING TO THE INITIAL REPORT RECEIVED ON (B)(6) 2025, THE CONSUMER REPORTED EXPERIENCING AN ALLERGIC REACTION AFTER THE SECOND USE. CONSUMER STATED MEDICAL ATTENTION WAS SOUGH (EMERGENCY CENTER).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319620 | AMAZON BASIC+CARE | HYDROCOLLOID GEL BANDAGES | NAD | EUROMED, INC. | UPC#195515047159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |