MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-12 for ESTEEM STRETCHY NITRATE 8817NB manufactured by Cardinal Health.
[94814919]
Rn removed glove from box and donned glove in usual fashion. Rn verbalized "gritty" sensation in glove. Glove removed and examined to find large brown foul foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073933 |
| MDR Report Key | 7112091 |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-12-08 |
| Date Added to Maude | 2017-12-13 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ESTEEM STRETCHY NITRATE |
| Generic Name | VINYL PATIENT EXAMINATION GLOVE |
| Product Code | LYZ |
| Date Received | 2017-12-12 |
| Model Number | 8817NB |
| Lot Number | 9C17K002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | DUBLIN OH 43017 US 43017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-12 |