MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-12 for N95 RESPIRATOR USA-N95-S manufactured by Cardinal Health 200, Llc.
[57202931]
Patient Sequence No: 1, Text Type: N, H10
[57202932]
During n95 annual fit testing of associates, our associate health nurse observed instances of the elastic strap pulling out from the mask seam. The lose strap prevented the mask from sealing properly or at all. In some cases, falling off the associate's face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6020486 |
| MDR Report Key | 6020486 |
| Date Received | 2016-10-12 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-09-12 |
| Report Date | 2016-09-12 |
| Date Reported to FDA | 2016-09-12 |
| Date Reported to Mfgr | 2016-09-12 |
| Date Added to Maude | 2016-10-12 |
| 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 |
| 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 | N95 RESPIRATOR |
| Generic Name | MASK, SURGICAL |
| Product Code | ORW |
| Date Received | 2016-10-12 |
| Model Number | USA-N95-S |
| Catalog Number | USA-N95-S |
| Lot Number | GJ120-00327 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 1500 WAUKEGAN RD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-12 |