FDA Adverse Event
Malfunction
Summary report: N
HALYARD
MDR report key: 19643092
·
Received July 1, 2024
Report
- Report Number
- 19643092
- Event Type
- Malfunction
- Date Received
- July 1, 2024
- Date of Event
- May 27, 2024
- Report Date
- June 3, 2024
- Manufacturer
- O&M HALYARD, INC.
- Product Code
- LZC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
THE HOSPITAL HAS SEEN SEVERAL INSTANCES OF GRAY NITRILE GLOVES TEARING DURING PATIENT CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 815627 | HALYARD | PATIENT EXAMINATION GLOVE, SPECIALTY | LZC | O&M HALYARD, INC. | 50708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |