FDA Adverse Event
Malfunction
Summary report: N
PREMIERPRO PLUS NITRILE EXAM GLOVES
MDR report key: 8892584
·
Received August 7, 2019
Report
- Report Number
- 8892584
- Event Type
- Malfunction
- Date Received
- August 7, 2019
- Date of Event
- June 1, 2019
- Report Date
- August 5, 2019
- Manufacturer
- SPS GLOBAL
- Product Code
- LZC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE LOT NUMBERS THAT ARE LISTED IN THE NEXT SECTION ARE THE AFFECTED NUMBERS FOR THE PREMIER PRO PLUS NITRILE EXAM GLOVES. THE GLOVES IN THESE LOT NUMBER HAVE BEEN FOUND TO HAVE A SIGNIFICANT AMOUNT OF DEBRIS IN THE FINGERS WHEN STAFF HAVE ATTEMPTED TO PUT THEM ON BEFORE PT CARE. NO PTS HAVE BEEN AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666577 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTH10-04 S 5062 | ||
| 666578 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTH11-03 S 5062 | ||
| 666579 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTH11-03 S 5062 | ||
| 666580 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTI03-36 L 5064 | ||
| 666581 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTI03-38 M 5063 | ||
| 666582 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTI01-20 S 5062 | ||
| 666583 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTI03-39 M 5063 | ||
| 666584 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTI03-35 S 5062 | ||
| 666585 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTH11-03 S 5062 | ||
| 666586 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTH11-04 XL 5065 | ||
| 666587 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTI03-40 S 5062 | ||
| 666588 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTH10-04 S 5062 | ||
| 666589 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTH10-05 L 5064 | ||
| 666590 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTH05-12 M 5063 | ||
| 666591 | PREMIERPRO PLUS NITRILE EXAM GLOVES | EXAM GLOVES | LZC | SPS GLOBAL | MTH05-12 L 5064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |