MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-25 for SENSICARE PF STERILE EXAM GLOVES 83292 205773789, 105179744 manufactured by Medline Industries.
[18855838]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2814242 |
| MDR Report Key | 2814242 |
| Date Received | 2012-10-25 |
| Date of Report | 2012-10-25 |
| Date of Event | 2012-10-23 |
| Report Date | 2012-10-25 |
| Date Reported to FDA | 2012-10-25 |
| Date Added to Maude | 2012-11-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSICARE PF STERILE EXAM GLOVES |
| Generic Name | POWDER-FREE VINYL, STERILE PATIENT EXAMINATION GLOVE |
| Product Code | LYZ |
| Date Received | 2012-10-25 |
| Returned To Mfg | 2012-10-26 |
| Model Number | 83292 |
| Catalog Number | 205773789, 105179744 |
| Lot Number | 205627548, 10517944, |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-25 |