MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for FLUIDSHIELD N95 PARTICULATE FILTER RESPIRATOR AND DUCKBILL SURGICAL MASK 46767 manufactured by Halyard Health, Inc..
[118411900]
We are having an issue with the duckbill mask 46767 from kimberly-clark. The lot number in question am9258b81. The elastic doesn't retract, just stretches and sometimes breaks. It looks like some of these masks could have dry rot. This was identified prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7822178 |
| MDR Report Key | 7822178 |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-08-14 |
| Report Date | 2018-08-15 |
| Date Reported to FDA | 2018-08-15 |
| Date Reported to Mfgr | 2018-08-28 |
| Date Added to Maude | 2018-08-28 |
| 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 | FLUIDSHIELD N95 PARTICULATE FILTER RESPIRATOR AND DUCKBILL SURGICAL MASK |
| Generic Name | MASK, SURGICAL |
| Product Code | FXX |
| Date Received | 2018-08-28 |
| Model Number | 46767 |
| Catalog Number | 46767 |
| Lot Number | AM9258B81 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-28 |