FDA Adverse Event
Injury
Summary report: N
FAK,COMPLETE,CURAD,175PC/KIT
MDR report key: 19415742
·
Received May 29, 2024
Report
- Report Number
- 1417592-2024-00626
- Event Type
- Injury
- Date Received
- May 29, 2024
- Date of Event
- May 1, 2024
- Report Date
- May 29, 2024
- Manufacturer
- MEDLINE INDUSTRIES LP
- Product Code
- LRR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE BANDAGE CAUSED A SECONDARY INFECTION WHEN PLACED OVER A "FUNGAL OR SKIN CONDITION THAT CAME ABOUT FROM AN INGROWN HAIR".IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION ADDED AS BECOMES AVAILABLE.
Description of Event or Problem · 0
UNKNOWN STAIN ON BANDAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1826093 | FAK,COMPLETE,CURAD,175PC/KIT | LRR | MEDLINE INDUSTRIES LP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |