FDA Adverse Event
Other
Summary report: N
SENSICARE POWDER FREE MEDICAL EXAMINATION GLOVES
MDR report key: 385557
·
Received March 29, 2002
Report
- Report Number
- 9615361-2002-00001
- Event Type
- Other
- Date Received
- March 29, 2002
- Report Date
- March 27, 2002
- Manufacturer
- MAXXIM MEDICAL CANADA LIMITED
- Product Code
- LYZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
HEALTHCARE WORKER IN HOSPITAL HAD TISSUE REACTION WHICH IS CLAIMED TO BE DUE TO THE GLOVES. THIS INDIVIDUAL WAS SUBSEQUENTLY HOSPITALIZED FOR BACTERIAL CELLULITUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSICARE POWDER FREE MEDICAL EXAMINATION GLOVES | NON-STERILE MEDICAL EXAMINATION GLOVES | LYZ | MAXXIM MEDICAL CANADA LIMITED | NA | 146HB08 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| O| R |