FDA Adverse Event
Malfunction
Summary report: N
PREMIERPRO PLUS NITRILE EXAM GLOVES - CHEMO TESTED
MDR report key: 20223509
·
Received September 16, 2024
Report
- Report Number
- 20223509
- Event Type
- Malfunction
- Date Received
- September 16, 2024
- Date of Event
- April 29, 2024
- Report Date
- May 13, 2024
- Manufacturer
- SVS LLC
- Product Code
- LZC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
GLOVE RIPPED UPON TRYING TO PUT ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1666400 | PREMIERPRO PLUS NITRILE EXAM GLOVES - CHEMO TESTED | PATIENT EXAMINATION GLOVE, SPECIALTY | LZC | SVS LLC | CFM09-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |