MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-05 for ESTEEM XP NITRILE * N8853XP manufactured by Cardinal Health Inc..
[21314816]
Gloves were pulled out of the box without difficulty and put on. A hole was in the thumb of the gloves. No harm to patient or staff. Hole was visibly evident. Another glove obtained and care continued. This facility has had multiple similar events with this device/product within a two month time span. The manufacturer has been notified and is testing the device/product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3672174 |
| MDR Report Key | 3672174 |
| Date Received | 2014-03-05 |
| Date of Report | 2014-02-24 |
| Date of Event | 2014-01-21 |
| Report Date | 2014-02-24 |
| Date Reported to FDA | 2014-03-05 |
| Date Reported to Mfgr | 2014-03-11 |
| Date Added to Maude | 2014-03-11 |
| 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 | 3 |
| 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 | ESTEEM XP NITRILE |
| Generic Name | PATIENT EXAMINATION GLOVE |
| Product Code | LZC |
| Date Received | 2014-03-05 |
| Model Number | * |
| Catalog Number | N8853XP |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH INC. |
| Manufacturer Address | 1430 WAUKEGAN RD-MPKB-2B MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-05 |