MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for CHEMOPLUS CHEMOTHERAPY PATIENT EXAMINATION GLOVES manufactured by Covidien.
[146481753]
A batch of chemoplus chemotherapy pt examination gloves had black, dirt-like particles on them. This was observed even after opening a new pair from its packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086943 |
| MDR Report Key | 8649939 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-05-23 |
| Date Added to Maude | 2019-05-29 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 CHEMOTHERAPY PATIENT EXAMINATION GLOVES |
| Generic Name | LATEX PATIENT EXAMINATION GLOVE |
| Product Code | LYY |
| Date Received | 2019-05-28 |
| Lot Number | 807829901 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-28 |