D
Patient 1
STERILE GLOVE USED DURING VAGINAL EXAM HAD IMPRINT OF INK FROM PACKAGING ON IT. UNCLEAR ON HOW LONG THIS MAY HAVE BEEN OCCURRING. ALL GLOVES WERE PULLED FROM PATIENT CARE AREAS (L&D, TRIAGE & AP) REPLACED WITH GLOVES FROM L&D OR.
MAUDE MDR 2814242
- MDR report key
- 2814242
- Report number
- 2814242
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-10-23
- Date received
- 2012-10-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SENSICARE PF STERILE EXAM GLOVES | POWDER-FREE VINYL, STERILE PATIENT EXAMINATION GLOVE | MEDLINE INDUSTRIES | LYZ | 83292 | 205773789, 105179744 | 205627548, 10517944, | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-10-25 | 0 |