MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for CHEMOPLUS CTS731M manufactured by Cardinal Health, Inc..
[145226966]
Chemotherapy gloves used to protect pharmacy staff from chemotherapy exposure are packaged with size large gloves in a package marked and sold as size medium.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8615308 |
| MDR Report Key | 8615308 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-04-18 |
| Report Date | 2019-05-14 |
| Date Reported to FDA | 2019-05-14 |
| Date Reported to Mfgr | 2019-05-16 |
| Date Added to Maude | 2019-05-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | CHEMOPLUS |
| Generic Name | POLYMER PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2019-05-16 |
| Model Number | CTS731M |
| Catalog Number | CTS731M |
| Lot Number | 3A100718 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |