MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for CHEMOPLUS CHEMO SPILL KIT CT4004 manufactured by Cardinal Health Llc / Covidien.
[145744698]
Chemoplus chemo spill kit contains latex gloves but has a label that says "not made with natural rubber latex. " supply was notified of the incorrect safety label but refuses to return effected product that contains latex.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086748 |
| MDR Report Key | 8624173 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-08 |
| Date of Event | 2019-05-01 |
| Date Added to Maude | 2019-05-20 |
| 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 | CHEMOPLUS CHEMO SPILL KIT |
| Generic Name | POLYMER PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2019-05-17 |
| Model Number | CT4004 |
| Lot Number | 826065X |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH LLC / COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-17 |