FDA Adverse Event
Malfunction
Summary report: N
FREEGUARD
MDR report key: 23108488
·
Received September 22, 2025
Report
- Report Number
- 23108488
- Event Type
- Malfunction
- Date Received
- September 22, 2025
- Date of Event
- July 30, 2025
- Report Date
- September 16, 2025
- Manufacturer
- ALIMED, INC.
- Product Code
- KGO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
RADIATION SURGICAL GLOVES X2 PAIRS WAS IDENTIFIED TO HAVE HOLES IN THE GLOVES. LOT#200124 ON BOTH PAIRS OPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2510865 | FREEGUARD | SURGEON'S GLOVES | KGO | ALIMED, INC. | 2970012763 | 200124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |