MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for CARDINAL FLEXAL NITRILE EXAM GLOVES 88TN02S manufactured by Cardinal Health 200, Llc.
[138908518]
Exam gloves and dispensing box have metal flakes found on them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084893 |
| MDR Report Key | 8420661 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-24 |
| Date Added to Maude | 2019-03-14 |
| 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 | RISK MANAGER |
| 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 | CARDINAL FLEXAL NITRILE EXAM GLOVES |
| Generic Name | POLYMER PATIENT EXAMINATION GLOVE |
| Product Code | LZA |
| Date Received | 2019-03-13 |
| Returned To Mfg | 2019-02-25 |
| Catalog Number | 88TN02S |
| Lot Number | 3T18P035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-13 |