MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for CARDINAL HEALTH N95-ML manufactured by Cardinal Health 200, Llc.
[184650139]
Multiple instances of the straps breaking when individual attempts to don mask on the cardinal n95 masks which makes the mask unusable. This has been occurring during testing and when used during patient care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9871295 |
| MDR Report Key | 9871295 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-21 |
| Report Date | 2020-03-20 |
| Date Reported to FDA | 2020-03-20 |
| Date Reported to Mfgr | 2020-03-24 |
| Date Added to Maude | 2020-03-24 |
| 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 | CARDINAL HEALTH |
| Generic Name | RESPIRATOR,SURGICAL |
| Product Code | MSH |
| Date Received | 2020-03-24 |
| Model Number | N95-ML |
| Catalog Number | N95-ML |
| Lot Number | JD12000555 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |