FDA Adverse Event
Other
Summary report: N
EQUATE ANTIBACTERIAL BANDAGES
MDR report key: 21312942
·
Received February 5, 2025
Report
- Report Number
- MW5165650
- Event Type
- Other
- Date Received
- February 5, 2025
- Date of Event
- January 15, 2025
- Report Date
- January 24, 2025
- Manufacturer
- TOTAL RESOURCES INTERNATIONAL INC.
- Product Code
- OHO
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
MOTHER ((B)(6)) APPLIED AN EQUATE STERILE ANTIBACTERIAL BANDAGE ON HER DAUGHTER'S ((B)(6)) STOMACH CLAIMING TO HAVE CAUSED A CHEMICAL BURN. PER MEDICAL VISIT SUMMARY: HISTORY OF MOLLUSCUM. DAUGHTER ((B)(6)) WAS ITCHING LAST NIGHT - MOTHER PUT AQUAPHOR ON IT LAST NIGHT - APPEARED TO BE A RECTANGLE OF BLISTERS. TODAY LOOKS LESS BLISTERY, NO FEVERS, NOT ITCHY, HURTS TO SCRATCHES, NO DRAINAGE. ASSESSMENT: RASH X 1DAY - GIVEN VERY DISCRETE OUTLINE MD SUSPECT CONTACT DERMATITIS ALTHOUGH UNCLEAR SOURCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631900 | EQUATE ANTIBACTERIAL BANDAGES | FIRST AID KIT WITHOUT DRUG | OHO | TOTAL RESOURCES INTERNATIONAL INC. | 658787610 | 23115.03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Female | Other |