MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-11 for FLUIDSHIELD* LEVEL 1 SURGICAL MASK WITH SO SOFT* LINING 28800 991028800 manufactured by O&m Halyard, Inc..
| Report Number | 9616096-2019-00003 |
| MDR Report Key | 8781850 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-07-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-04-16 |
| Device Manufacturer Date | 2018-12-28 |
| Date Added to Maude | 2019-07-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer Contact | MR. SCOTT MCKENTLY |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485926 |
| Manufacturer G1 | AVENT ACUNA |
| Manufacturer Street | CARRETERA PRESA LA AMISTAD KM PARQUE INDUSTRIAL AMISTAD |
| Manufacturer City | CD. ACU 26220 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 26220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUIDSHIELD* LEVEL 1 SURGICAL MASK WITH SO SOFT* LINING |
| Generic Name | ICP FACIAL PROTECTION PRODUCTS |
| Product Code | FXX |
| Date Received | 2019-07-11 |
| Returned To Mfg | 2019-03-21 |
| Model Number | 28800 |
| Catalog Number | 991028800 |
| Lot Number | AM8361041 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | O&M HALYARD, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-11 |